U.S. patent number 11,426,155 [Application Number 16/680,739] was granted by the patent office on 2022-08-30 for helical anchor implantation.
This patent grant is currently assigned to CARDIOVALVE LTD.. The grantee listed for this patent is CARDIOVALVE LTD.. Invention is credited to Yossi Gross, Gil Hacohen, Tal Reich.
United States Patent |
11,426,155 |
Hacohen , et al. |
August 30, 2022 |
Helical anchor implantation
Abstract
A transluminal sheath is advanced into a femoral vein of a
subject, through an inferior vena cava of the subject, into a right
atrium of a heart of the subject, and transseptally into a left
atrium of the heart. A surrounding-sheath is advanced out of a
distal end of the transluminal sheath, into the left atrium, and
toward a commissure of a mitral valve of the heart. A commissural
helix is implanted at the commissure by advancing the commissural
helix out of the surrounding-sheath and through the commissure into
a left ventricle of the heart, such that the commissural helix
wraps around at least some chordae tendineae at the commissure and
facilitates sealing of the commissure. Subsequently to the
implantation of the commissural helix, the surrounding-sheath is
extracted from the heart. Other embodiments are also described.
Inventors: |
Hacohen; Gil (Ramat Gan,
IL), Gross; Yossi (Moshav Mazor, IL),
Reich; Tal (Moshav Moledet, IL) |
Applicant: |
Name |
City |
State |
Country |
Type |
CARDIOVALVE LTD. |
Or Yehuda |
N/A |
IL |
|
|
Assignee: |
CARDIOVALVE LTD. (Or Yehuda,
IL)
|
Family
ID: |
1000006531278 |
Appl.
No.: |
16/680,739 |
Filed: |
November 12, 2019 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20200078002 A1 |
Mar 12, 2020 |
|
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
15691032 |
Aug 30, 2017 |
10512456 |
|
|
|
14689608 |
Apr 17, 2015 |
9763657 |
|
|
|
13811308 |
|
9017399 |
|
|
|
PCT/IL2011/000582 |
Jul 21, 2011 |
|
|
|
|
13033852 |
Feb 24, 2011 |
8992604 |
|
|
|
12840463 |
Jul 21, 2010 |
9132009 |
|
|
|
12840463 |
Jul 21, 2010 |
9132009 |
|
|
|
61492449 |
Jun 2, 2011 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/2457 (20130101); A61F 2/2418 (20130101); A61F
2/2409 (20130101); A61B 17/0401 (20130101); A61F
2/2436 (20130101); A61F 2/243 (20130101); A61F
2/2427 (20130101); A61B 2017/0441 (20130101); A61B
2017/00243 (20130101); A61F 2/2412 (20130101); A61F
2/2466 (20130101); A61B 2017/0464 (20130101); A61F
2220/0016 (20130101); A61F 2230/0041 (20130101); A61F
2230/005 (20130101) |
Current International
Class: |
A61B
17/04 (20060101); A61F 2/24 (20060101); A61B
17/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
|
|
|
3874388 |
April 1975 |
King et al. |
4222126 |
September 1980 |
Boretos et al. |
4261342 |
April 1981 |
Aranguren Guo |
4340091 |
July 1982 |
Skelton et al. |
4423525 |
January 1984 |
Vallana et al. |
4853986 |
August 1989 |
Allen |
4892541 |
January 1990 |
Alonso |
4972494 |
November 1990 |
White et al. |
5108420 |
April 1992 |
Marks |
5201757 |
April 1993 |
Heyn et al. |
5314473 |
May 1994 |
Godin |
5405378 |
April 1995 |
Strecker |
5443500 |
August 1995 |
Sigwart |
5607444 |
March 1997 |
Lam |
5607470 |
March 1997 |
Milo |
5647857 |
July 1997 |
Anderson et al. |
5713948 |
February 1998 |
Uflacker |
5716417 |
February 1998 |
Girard et al. |
5741297 |
April 1998 |
Simon |
5765682 |
June 1998 |
Bley et al. |
5776140 |
July 1998 |
Cottone |
5868777 |
February 1999 |
Lam |
5873906 |
February 1999 |
Lau et al. |
5954766 |
September 1999 |
Zadno-Azizi et al. |
5957949 |
September 1999 |
Leonhardt et al. |
5980565 |
November 1999 |
Jayaraman |
6010530 |
January 2000 |
Goicoechea |
6019787 |
February 2000 |
Richard et al. |
6042607 |
March 2000 |
Williamson, IV et al. |
6074417 |
June 2000 |
Peredo |
6113612 |
September 2000 |
Swanson et al. |
6120534 |
September 2000 |
Ruiz |
6126686 |
October 2000 |
Badylak et al. |
6152937 |
November 2000 |
Peterson et al. |
6165183 |
December 2000 |
Kuehn et al. |
6165210 |
December 2000 |
Lau et al. |
6172898 |
January 2001 |
Kajiyama |
6187020 |
February 2001 |
Zegdi et al. |
6193745 |
February 2001 |
Fogarty et al. |
6254609 |
July 2001 |
Vrba et al. |
6264700 |
July 2001 |
Kilcoyne et al. |
6287339 |
September 2001 |
Vazquez et al. |
6312465 |
November 2001 |
Griffin et al. |
6332893 |
December 2001 |
Mortier et al. |
6334873 |
January 2002 |
Lane et al. |
6346074 |
February 2002 |
Roth |
6350278 |
February 2002 |
Lenker et al. |
6352561 |
March 2002 |
Leopold et al. |
6391036 |
May 2002 |
Berg et al. |
6402780 |
June 2002 |
Williamson, IV et al. |
6409755 |
June 2002 |
Vrba |
6419696 |
July 2002 |
Ortiz et al. |
6428550 |
August 2002 |
Vargas et al. |
6440164 |
August 2002 |
DiMatteo et al. |
6454799 |
September 2002 |
Schreck |
6458153 |
October 2002 |
Bailey et al. |
6511491 |
January 2003 |
Grudem et al. |
6530952 |
March 2003 |
Vesely |
6540782 |
April 2003 |
Snyders |
6551350 |
April 2003 |
Thornton et al. |
6558418 |
May 2003 |
Inoue |
6569196 |
May 2003 |
Vesely |
6602263 |
August 2003 |
Swanson et al. |
6616675 |
September 2003 |
Evard et al. |
6652556 |
November 2003 |
VanTassel et al. |
6669724 |
December 2003 |
Park et al. |
6682558 |
January 2004 |
Tu et al. |
6699256 |
March 2004 |
Logan et al. |
6716244 |
April 2004 |
Klaco |
6719781 |
April 2004 |
Kim |
6730118 |
May 2004 |
Spenser et al. |
6730121 |
May 2004 |
Ortiz et al. |
6733525 |
May 2004 |
Yang et al. |
6752813 |
June 2004 |
Goldfarb et al. |
6764518 |
July 2004 |
Godin |
6767362 |
July 2004 |
Schreck |
6797002 |
September 2004 |
Spence et al. |
6821297 |
November 2004 |
Snyders |
6830585 |
December 2004 |
Artof et al. |
6830638 |
December 2004 |
Boylan et al. |
6893460 |
May 2005 |
Spenser et al. |
6926715 |
August 2005 |
Hauck et al. |
6951571 |
October 2005 |
Srivastava et al. |
6960217 |
November 2005 |
Bolduc |
6964684 |
November 2005 |
Ortiz et al. |
6974476 |
December 2005 |
McGuckin, Jr. et al. |
7011681 |
March 2006 |
Vesely |
7018406 |
March 2006 |
Seguin et al. |
7041132 |
May 2006 |
Quijano et al. |
7074236 |
July 2006 |
Rabkin et al. |
7077861 |
July 2006 |
Spence |
7101395 |
September 2006 |
Tremulis et al. |
7101396 |
September 2006 |
Artof et al. |
7137184 |
November 2006 |
Schreck |
7172625 |
February 2007 |
Shu et al. |
7198646 |
April 2007 |
Figulla et al. |
7201772 |
April 2007 |
Schwammenthal et al. |
7226467 |
June 2007 |
Lucatero et al. |
7226477 |
June 2007 |
Cox |
7261686 |
August 2007 |
Couvillon, Jr. |
7288097 |
October 2007 |
Seguin |
7288111 |
October 2007 |
Holloway et al. |
7316716 |
January 2008 |
Egan |
7318219 |
January 2008 |
Hall |
7329279 |
February 2008 |
Haug et al. |
7335213 |
February 2008 |
Hyde et al. |
7351256 |
April 2008 |
Hojeibane et al. |
7374573 |
May 2008 |
Gabbay |
7377938 |
May 2008 |
Sarac et al. |
7381218 |
June 2008 |
Schreck |
7404824 |
July 2008 |
Webler et al. |
7422603 |
September 2008 |
Lane |
7429269 |
September 2008 |
Schwammenthal et al. |
7442204 |
October 2008 |
Schwammenthal et al. |
7445630 |
November 2008 |
Lashinski et al. |
7455677 |
November 2008 |
Vargas et al. |
7455688 |
November 2008 |
Furst et al. |
7462162 |
December 2008 |
Phan et al. |
7481838 |
January 2009 |
Carpentier et al. |
7510575 |
March 2009 |
Spenser et al. |
7513909 |
April 2009 |
Lane et al. |
7524331 |
April 2009 |
Birdsall |
7527646 |
May 2009 |
Rahdert et al. |
7556632 |
July 2009 |
Zadno |
7556646 |
July 2009 |
Yang et al. |
7563267 |
July 2009 |
Goldfarb et al. |
7563273 |
July 2009 |
Goldfarb et al. |
7582111 |
September 2009 |
Krolik et al. |
7585321 |
September 2009 |
Cribier et al. |
7597711 |
October 2009 |
Drews et al. |
7608091 |
October 2009 |
Goldfarb et al. |
7611534 |
November 2009 |
Kapadia et al. |
7621948 |
November 2009 |
Hermann et al. |
7625403 |
December 2009 |
Krivoruchko et al. |
7632302 |
December 2009 |
Vreeman et al. |
7635329 |
December 2009 |
Goldfarb et al. |
7648528 |
January 2010 |
Styrc |
7655015 |
February 2010 |
Goldfarb et al. |
7682380 |
March 2010 |
Thornton et al. |
7708775 |
May 2010 |
Rowe et al. |
7717952 |
May 2010 |
Case et al. |
7717955 |
May 2010 |
Lane et al. |
7731741 |
June 2010 |
Eidenschink |
7736388 |
June 2010 |
Goldfarb et al. |
7748389 |
July 2010 |
Salahieh et al. |
7753922 |
July 2010 |
Starksen |
7753949 |
July 2010 |
Lamphere et al. |
7758595 |
July 2010 |
Allen et al. |
7758632 |
July 2010 |
Hojeibane et al. |
7758640 |
July 2010 |
Vesely |
7771467 |
August 2010 |
Svensson |
7771469 |
August 2010 |
Liddicoat |
7776083 |
August 2010 |
Vesely |
7780726 |
August 2010 |
Seguin |
7799069 |
September 2010 |
Bailey et al. |
7803181 |
September 2010 |
Furst et al. |
7811296 |
October 2010 |
Goldfarb et al. |
7811316 |
October 2010 |
Kalmann et al. |
7824442 |
November 2010 |
Salahieh et al. |
7837645 |
November 2010 |
Bessler et al. |
7837727 |
November 2010 |
Goetz et al. |
7842081 |
November 2010 |
Yadin |
7850725 |
December 2010 |
Vardi et al. |
7871432 |
January 2011 |
Bergin |
7871436 |
January 2011 |
Ryan et al. |
7887583 |
February 2011 |
Macoviak |
7892281 |
February 2011 |
Seguin et al. |
7896915 |
March 2011 |
Guyenot et al. |
7914544 |
March 2011 |
Nguyen et al. |
7914569 |
March 2011 |
Nguyen et al. |
7927370 |
April 2011 |
Webler et al. |
7942927 |
May 2011 |
Kaye et al. |
7947072 |
May 2011 |
Yang et al. |
7947075 |
May 2011 |
Goetz et al. |
7951195 |
May 2011 |
Antonsson et al. |
7955375 |
June 2011 |
Agnew |
7955377 |
June 2011 |
Melsheimer |
7955384 |
June 2011 |
Rafiee et al. |
7959666 |
June 2011 |
Salahieh et al. |
7959672 |
June 2011 |
Salahieh et al. |
7967833 |
June 2011 |
Sterman et al. |
7967857 |
June 2011 |
Lane |
7981151 |
July 2011 |
Rowe |
7981153 |
July 2011 |
Fogarty et al. |
7992567 |
August 2011 |
Hirotsuka et al. |
7993393 |
August 2011 |
Carpentier et al. |
8002825 |
August 2011 |
Letac et al. |
8002826 |
August 2011 |
Seguin |
8016877 |
September 2011 |
Seguin et al. |
8016882 |
September 2011 |
Macoviak et al. |
8021420 |
September 2011 |
Dolan |
8021421 |
September 2011 |
Fogarty et al. |
8025695 |
September 2011 |
Fogarty et al. |
8029518 |
October 2011 |
Goldfarb et al. |
8029557 |
October 2011 |
Sobrino-Serrano et al. |
8029564 |
October 2011 |
Johnson et al. |
8034104 |
October 2011 |
Carpentier et al. |
8038720 |
October 2011 |
Wallace et al. |
8043360 |
October 2011 |
McNamara et al. |
8048138 |
November 2011 |
Sullivan et al. |
8048140 |
November 2011 |
Purdy |
8048153 |
November 2011 |
Salahieh et al. |
8052592 |
November 2011 |
Goldfarb et al. |
8052741 |
November 2011 |
Bruszewski et al. |
8052749 |
November 2011 |
Salahieh et al. |
8057493 |
November 2011 |
Goldfarb et al. |
8057532 |
November 2011 |
Hoffman |
8057540 |
November 2011 |
Letac et al. |
8062355 |
November 2011 |
Figulla et al. |
8062359 |
November 2011 |
Marquez et al. |
8070708 |
December 2011 |
Rottenberg et al. |
8070800 |
December 2011 |
Lock et al. |
8070802 |
December 2011 |
Lamphere et al. |
8070804 |
December 2011 |
Hyde et al. |
8075611 |
December 2011 |
Millwee et al. |
8080054 |
December 2011 |
Rowe |
8083793 |
December 2011 |
Lane et al. |
D652927 |
January 2012 |
Braido et al. |
D653341 |
January 2012 |
Braido et al. |
8092518 |
January 2012 |
Schreck |
8092520 |
January 2012 |
Quadri |
8092521 |
January 2012 |
Figulla et al. |
8105377 |
January 2012 |
Liddicoat |
8109996 |
February 2012 |
Stacchino et al. |
8118866 |
February 2012 |
Hermann et al. |
8133270 |
March 2012 |
Kheradvar et al. |
8136218 |
March 2012 |
Millwee et al. |
8137398 |
March 2012 |
Tuval et al. |
8142492 |
March 2012 |
Forster et al. |
8142494 |
March 2012 |
Rahdert et al. |
8142496 |
March 2012 |
Berreklouw |
8142497 |
March 2012 |
Friedman |
8147504 |
April 2012 |
Ino et al. |
8157852 |
April 2012 |
Bloom et al. |
8157853 |
April 2012 |
Laske et al. |
8157860 |
April 2012 |
McNamara et al. |
8163008 |
April 2012 |
Wilson et al. |
8163014 |
April 2012 |
Lane et al. |
D660433 |
May 2012 |
Braido et al. |
D660967 |
May 2012 |
Braido et al. |
8167894 |
May 2012 |
Miles et al. |
8167932 |
May 2012 |
Bourang et al. |
8167935 |
May 2012 |
McGuckin, Jr. et al. |
8172896 |
May 2012 |
McNamara et al. |
8177836 |
May 2012 |
Lee et al. |
8182528 |
May 2012 |
Salahieh et al. |
8211169 |
July 2012 |
Lane et al. |
8216256 |
July 2012 |
Raschdorf, Jr. et al. |
8216301 |
July 2012 |
Bonhoeffer et al. |
8221492 |
July 2012 |
Case et al. |
8221493 |
July 2012 |
Boyle et al. |
8226710 |
July 2012 |
Nguyen et al. |
8231670 |
July 2012 |
Salahieh et al. |
8236045 |
August 2012 |
Benichou et al. |
8236049 |
August 2012 |
Rowe et al. |
8252042 |
August 2012 |
McNamara et al. |
8252051 |
August 2012 |
Chau et al. |
8252052 |
August 2012 |
Salahieh et al. |
8257390 |
September 2012 |
Carley et al. |
8267988 |
September 2012 |
Hamer et al. |
8277501 |
October 2012 |
Chalekian et al. |
8287591 |
October 2012 |
Keidar et al. |
8298280 |
October 2012 |
Yadin et al. |
8303653 |
November 2012 |
Bonhoeffer et al. |
8308798 |
November 2012 |
Pintor et al. |
8317853 |
November 2012 |
Agnew |
8317855 |
November 2012 |
Gregorich et al. |
8323335 |
December 2012 |
Rowe et al. |
8328868 |
December 2012 |
Paul et al. |
8337541 |
December 2012 |
Quadri et al. |
8343174 |
January 2013 |
Goldfarb et al. |
8343213 |
January 2013 |
Salahieh et al. |
8348999 |
January 2013 |
Kheradvar et al. |
8366767 |
February 2013 |
Zhang |
8372140 |
February 2013 |
Hoffman et al. |
8377119 |
February 2013 |
Drews et al. |
8398708 |
March 2013 |
Meiri et al. |
8403981 |
March 2013 |
Forster et al. |
8403983 |
March 2013 |
Quadri et al. |
8408214 |
April 2013 |
Spenser |
8414644 |
April 2013 |
Quadri et al. |
8425593 |
April 2013 |
Braido et al. |
8430934 |
April 2013 |
Das |
8444689 |
May 2013 |
Zhang |
8449599 |
May 2013 |
Chau et al. |
8449625 |
May 2013 |
Campbell et al. |
8454686 |
June 2013 |
Alkhatib |
8460365 |
June 2013 |
Haverkost et al. |
8474460 |
July 2013 |
Barrett et al. |
8500821 |
August 2013 |
Sobrino-Serrano et al. |
8512400 |
August 2013 |
Tran et al. |
8539662 |
September 2013 |
Stacchino et al. |
8545544 |
October 2013 |
Spenser et al. |
8551160 |
October 2013 |
Figulla et al. |
8551161 |
October 2013 |
Dolan |
8562672 |
October 2013 |
Bonhoeffer et al. |
8568475 |
October 2013 |
Nguyen et al. |
8579964 |
November 2013 |
Lane et al. |
8579965 |
November 2013 |
Bonhoeffer et al. |
8585755 |
November 2013 |
Chau et al. |
8585756 |
November 2013 |
Bonhoeffer et al. |
8591460 |
November 2013 |
Wilson et al. |
8591570 |
November 2013 |
Revuelta et al. |
8623075 |
January 2014 |
Murray, III et al. |
8623080 |
January 2014 |
Fogarty et al. |
8628569 |
January 2014 |
Benichou et al. |
8628570 |
January 2014 |
Seguin |
8628571 |
January 2014 |
Hacohen et al. |
8652203 |
February 2014 |
Quadri et al. |
8652204 |
February 2014 |
Quill et al. |
8657872 |
February 2014 |
Seguin |
8663322 |
March 2014 |
Keranen |
8673020 |
March 2014 |
Sobrino-Serrano et al. |
8679174 |
March 2014 |
Ottma et al. |
8685086 |
April 2014 |
Navia et al. |
8696742 |
April 2014 |
Pintor et al. |
8728155 |
May 2014 |
Montorfano et al. |
8734507 |
May 2014 |
Keranen |
8747460 |
June 2014 |
Tuval et al. |
8771345 |
July 2014 |
Tuval et al. |
8784472 |
July 2014 |
Eidenschink |
8784479 |
July 2014 |
Tuval et al. |
8784481 |
July 2014 |
Alkhatib et al. |
8795355 |
August 2014 |
Alkhatib |
8795356 |
August 2014 |
Quadri et al. |
8795357 |
August 2014 |
Yohanan et al. |
8801776 |
August 2014 |
House et al. |
8808366 |
August 2014 |
Braido et al. |
8840663 |
September 2014 |
Salahieh et al. |
8840664 |
September 2014 |
Karapetian et al. |
8845722 |
September 2014 |
Gabbay |
8852261 |
October 2014 |
White |
8852272 |
October 2014 |
Gross et al. |
8870948 |
October 2014 |
Erzberger et al. |
8870949 |
October 2014 |
Rowe |
8870950 |
October 2014 |
Hacohen |
8876800 |
November 2014 |
Behan |
8894702 |
November 2014 |
Quadri et al. |
8900294 |
December 2014 |
Paniagua et al. |
8900295 |
December 2014 |
Migliazza et al. |
8906083 |
December 2014 |
Obermiller et al. |
8911455 |
December 2014 |
Quadri et al. |
8911489 |
December 2014 |
Ben-Muvhar |
8911493 |
December 2014 |
Rowe et al. |
8932343 |
January 2015 |
Alkhatib et al. |
8961595 |
February 2015 |
Alkhatib |
8979922 |
March 2015 |
Jayasinghe et al. |
8986370 |
March 2015 |
Annest |
8986373 |
March 2015 |
Chau et al. |
8986375 |
March 2015 |
Garde et al. |
8992599 |
March 2015 |
Thubrikar et al. |
8992604 |
March 2015 |
Gross et al. |
8998982 |
April 2015 |
Richter et al. |
9005273 |
April 2015 |
Salahieh et al. |
9011468 |
April 2015 |
Ketai et al. |
9011527 |
April 2015 |
Li et al. |
9017399 |
April 2015 |
Gross et al. |
D730520 |
May 2015 |
Braido et al. |
D730521 |
May 2015 |
Braido et al. |
9023100 |
May 2015 |
Quadri et al. |
9034032 |
May 2015 |
McLean et al. |
9034033 |
May 2015 |
McLean et al. |
9039757 |
May 2015 |
McLean et al. |
D732666 |
June 2015 |
Nguyen et al. |
9048676 |
June 2015 |
Tsuji et al. |
9050188 |
June 2015 |
Schweich, Jr. et al. |
9060858 |
June 2015 |
Thornton et al. |
9072603 |
July 2015 |
Tuval et al. |
9095434 |
August 2015 |
Rowe |
9119719 |
September 2015 |
Zipory et al. |
9125738 |
September 2015 |
Figulla et al. |
9125740 |
September 2015 |
Morriss et al. |
9132006 |
September 2015 |
Spenser et al. |
9132009 |
September 2015 |
Hacohen et al. |
9138312 |
September 2015 |
Tuval et al. |
9155619 |
October 2015 |
Liu et al. |
9173659 |
November 2015 |
Bodewadt et al. |
9173738 |
November 2015 |
Murray, III et al. |
9220594 |
December 2015 |
Braido et al. |
9226820 |
January 2016 |
Braido et al. |
9226839 |
January 2016 |
Kariniemi et al. |
9232995 |
January 2016 |
Kovalsky et al. |
9241790 |
January 2016 |
Lane et al. |
9241791 |
January 2016 |
Braido et al. |
9241792 |
January 2016 |
Benichou et al. |
9241794 |
January 2016 |
Braido et al. |
9248014 |
February 2016 |
Lane et al. |
9277994 |
March 2016 |
Miller et al. |
9289290 |
March 2016 |
Alkhatib et al. |
9289291 |
March 2016 |
Gorman, III et al. |
9295550 |
March 2016 |
Nguyen et al. |
9295551 |
March 2016 |
Straubinger et al. |
9295552 |
March 2016 |
McLean et al. |
9301836 |
April 2016 |
Buchbinder et al. |
9320591 |
April 2016 |
Bolduc |
D755384 |
May 2016 |
Pesce et al. |
9326852 |
May 2016 |
Spenser |
9326876 |
May 2016 |
Acosta et al. |
9345573 |
May 2016 |
Nyuli et al. |
9387078 |
July 2016 |
Gross et al. |
9393110 |
July 2016 |
Levi et al. |
9421098 |
August 2016 |
Gifford, III et al. |
9427303 |
August 2016 |
Liddy et al. |
9427316 |
August 2016 |
Schweich, Jr. et al. |
9439757 |
September 2016 |
Wallace et al. |
9463102 |
October 2016 |
Kelly |
9474599 |
October 2016 |
Keranen |
9474638 |
October 2016 |
Robinson et al. |
9480559 |
November 2016 |
Vidlund et al. |
9492273 |
November 2016 |
Wallace et al. |
9498314 |
November 2016 |
Behan |
9532870 |
January 2017 |
Cooper et al. |
9554897 |
January 2017 |
Lane et al. |
9554899 |
January 2017 |
Granada et al. |
9561103 |
February 2017 |
Granada et al. |
9566152 |
February 2017 |
Schweich, Jr. et al. |
9597182 |
March 2017 |
Straubinger et al. |
9629716 |
April 2017 |
Seguin |
9662203 |
May 2017 |
Sheahan et al. |
9681952 |
June 2017 |
Hacohen |
9717591 |
August 2017 |
Chau et al. |
9743932 |
August 2017 |
Amplatz et al. |
9763657 |
September 2017 |
Hacohen et al. |
9763817 |
September 2017 |
Roeder |
9770256 |
September 2017 |
Cohen et al. |
D800908 |
October 2017 |
Hariton et al. |
9788941 |
October 2017 |
Hacohen |
9895226 |
February 2018 |
Harari et al. |
9987132 |
June 2018 |
Hariton et al. |
10010414 |
July 2018 |
Cooper et al. |
10076415 |
September 2018 |
Metchik et al. |
10105222 |
October 2018 |
Metchik et al. |
10111751 |
October 2018 |
Metchik et al. |
10123873 |
November 2018 |
Metchik et al. |
10130475 |
November 2018 |
Metchik et al. |
10136993 |
November 2018 |
Metchik et al. |
10143552 |
December 2018 |
Wallace et al. |
10149761 |
December 2018 |
Granada et al. |
10154906 |
December 2018 |
Granada et al. |
10159570 |
December 2018 |
Metchik et al. |
10182908 |
January 2019 |
Tubishevitz et al. |
10226341 |
March 2019 |
Gross et al. |
10231837 |
March 2019 |
Metchik et al. |
10238493 |
March 2019 |
Metchik et al. |
10245143 |
April 2019 |
Gross et al. |
10245144 |
April 2019 |
Metchik et al. |
10258471 |
April 2019 |
Lutter et al. |
10292816 |
May 2019 |
Raanani et al. |
10299927 |
May 2019 |
McLean et al. |
10321995 |
June 2019 |
Christianson et al. |
10322020 |
June 2019 |
Lam et al. |
10327895 |
June 2019 |
Lozonschi et al. |
10335278 |
July 2019 |
McLean et al. |
10376361 |
August 2019 |
Gross et al. |
10507108 |
December 2019 |
Delgado et al. |
10507109 |
December 2019 |
Metchik et al. |
10512456 |
December 2019 |
Hacohen et al. |
10517719 |
December 2019 |
Miller et al. |
10524792 |
January 2020 |
Hemandez et al. |
10531866 |
January 2020 |
Hariton et al. |
10531872 |
January 2020 |
Hacohen et al. |
10548731 |
February 2020 |
Lashinski et al. |
10575948 |
March 2020 |
Iamberger et al. |
10595992 |
March 2020 |
Chambers |
10595997 |
March 2020 |
Metchik et al. |
10610358 |
April 2020 |
Vidlund et al. |
10646342 |
May 2020 |
Marr et al. |
10702385 |
July 2020 |
Hacohen et al. |
10758342 |
September 2020 |
Chau et al. |
10813760 |
October 2020 |
Metchik et al. |
10820998 |
November 2020 |
Marr et al. |
10842627 |
November 2020 |
Delgado et al. |
10856975 |
December 2020 |
Hariton et al. |
10856978 |
December 2020 |
Straubinger et al. |
10874514 |
December 2020 |
Dixon et al. |
10888425 |
January 2021 |
Delgado et al. |
10888644 |
January 2021 |
Ratz et al. |
10905552 |
February 2021 |
Dixon et al. |
10905554 |
February 2021 |
Cao |
10918483 |
February 2021 |
Metchik et al. |
10925732 |
February 2021 |
Delgado et al. |
10945843 |
March 2021 |
Delgado et al. |
10945844 |
March 2021 |
McCann et al. |
10993809 |
May 2021 |
McCann et al. |
11065114 |
July 2021 |
Raanani et al. |
11083582 |
August 2021 |
McCann et al. |
11147672 |
October 2021 |
McCann et al. |
11179240 |
November 2021 |
Delgado et al. |
11291545 |
April 2022 |
Hacohen |
11291546 |
April 2022 |
Gross et al. |
11291547 |
April 2022 |
Gross et al. |
2001/0002445 |
May 2001 |
Vesely |
2001/0005787 |
June 2001 |
Oz et al. |
2001/0021872 |
September 2001 |
Bailey et al. |
2001/0056295 |
December 2001 |
Solem |
2002/0013571 |
January 2002 |
Goldfarb et al. |
2002/0032481 |
March 2002 |
Gabbay |
2002/0099436 |
July 2002 |
Thornton et al. |
2002/0151970 |
October 2002 |
Garrison et al. |
2002/0177894 |
November 2002 |
Acosta et al. |
2003/0036791 |
February 2003 |
Philipp et al. |
2003/0050694 |
March 2003 |
Yang et al. |
2003/0060875 |
March 2003 |
Wittens |
2003/0069635 |
April 2003 |
Cartledge et al. |
2003/0074052 |
April 2003 |
Besselink |
2003/0083742 |
May 2003 |
Spence et al. |
2003/0105519 |
June 2003 |
Fasol et al. |
2003/0158578 |
August 2003 |
Pantages et al. |
2004/0010272 |
January 2004 |
Manetakis et al. |
2004/0030382 |
February 2004 |
St. Goar et al. |
2004/0039414 |
February 2004 |
Carley et al. |
2004/0093060 |
May 2004 |
Seguin et al. |
2004/0122503 |
June 2004 |
Campbell et al. |
2004/0122514 |
June 2004 |
Fogarty et al. |
2004/0133267 |
July 2004 |
Lane |
2004/0143315 |
July 2004 |
Bruun et al. |
2004/0176839 |
September 2004 |
Huynh et al. |
2004/0186558 |
September 2004 |
Pavcnik et al. |
2004/0186565 |
September 2004 |
Schreck |
2004/0186566 |
September 2004 |
Hindrichs et al. |
2004/0210244 |
October 2004 |
Vargas et al. |
2004/0210304 |
October 2004 |
Seguin et al. |
2004/0220593 |
November 2004 |
Greenhalgh |
2004/0225354 |
November 2004 |
Allen et al. |
2004/0236354 |
November 2004 |
Seguin |
2004/0249433 |
December 2004 |
Freitag |
2004/0260389 |
December 2004 |
Case et al. |
2004/0260394 |
December 2004 |
Douk et al. |
2005/0004668 |
January 2005 |
Aklog et al. |
2005/0021056 |
January 2005 |
St. Goar et al. |
2005/0027305 |
February 2005 |
Shiu et al. |
2005/0027348 |
February 2005 |
Case et al. |
2005/0038494 |
February 2005 |
Eidenschink |
2005/0055086 |
March 2005 |
Stobie |
2005/0075731 |
April 2005 |
Artof et al. |
2005/0080430 |
April 2005 |
Wright, Jr. et al. |
2005/0080474 |
April 2005 |
Andreas et al. |
2005/0085900 |
April 2005 |
Case et al. |
2005/0137686 |
June 2005 |
Salahieh et al. |
2005/0137688 |
June 2005 |
Salahieh et al. |
2005/0137689 |
June 2005 |
Salahieh et al. |
2005/0137690 |
June 2005 |
Salahieh et al. |
2005/0137691 |
June 2005 |
Salahieh et al. |
2005/0137692 |
June 2005 |
Haug et al. |
2005/0137695 |
June 2005 |
Salahieh et al. |
2005/0137697 |
June 2005 |
Salahieh et al. |
2005/0143809 |
June 2005 |
Salahieh et al. |
2005/0154443 |
July 2005 |
Linder et al. |
2005/0182486 |
August 2005 |
Gabbay |
2005/0197695 |
September 2005 |
Stacchino et al. |
2005/0203549 |
September 2005 |
Realyvasquez |
2005/0203618 |
September 2005 |
Sharkawy et al. |
2005/0216079 |
September 2005 |
MaCoviak |
2005/0234508 |
October 2005 |
Cummins et al. |
2005/0240200 |
October 2005 |
Bergheim |
2005/0251251 |
November 2005 |
Cribier |
2005/0256566 |
November 2005 |
Gabbay |
2005/0267573 |
December 2005 |
Macoviak et al. |
2006/0004439 |
January 2006 |
Spenser et al. |
2006/0004469 |
January 2006 |
Sokel |
2006/0015171 |
January 2006 |
Armstrong |
2006/0020275 |
January 2006 |
Goldfarb et al. |
2006/0020327 |
January 2006 |
Lashinski et al. |
2006/0020333 |
January 2006 |
Lashinski |
2006/0041189 |
February 2006 |
Vancaillie |
2006/0047297 |
March 2006 |
Case |
2006/0052867 |
March 2006 |
Revuelta et al. |
2006/0089627 |
April 2006 |
Burnett et al. |
2006/0111773 |
May 2006 |
Rittgers et al. |
2006/0116750 |
June 2006 |
Hebert et al. |
2006/0135964 |
June 2006 |
Vesely |
2006/0155357 |
July 2006 |
Melsheimer |
2006/0178700 |
August 2006 |
Quinn |
2006/0178740 |
August 2006 |
Stacchino et al. |
2006/0184203 |
August 2006 |
Martin et al. |
2006/0190036 |
August 2006 |
Wendel et al. |
2006/0190038 |
August 2006 |
Carley et al. |
2006/0195183 |
August 2006 |
Navia et al. |
2006/0195184 |
August 2006 |
Lane et al. |
2006/0201519 |
September 2006 |
Frazier et al. |
2006/0212111 |
September 2006 |
Case et al. |
2006/0216404 |
September 2006 |
Seyler et al. |
2006/0229708 |
October 2006 |
Powell et al. |
2006/0241656 |
October 2006 |
Starksen et al. |
2006/0241745 |
October 2006 |
Solem |
2006/0241748 |
October 2006 |
Lee et al. |
2006/0247680 |
November 2006 |
Amplatz et al. |
2006/0253191 |
November 2006 |
Salahieh et al. |
2006/0259136 |
November 2006 |
Nguyen et al. |
2006/0259137 |
November 2006 |
Artof et al. |
2006/0271166 |
November 2006 |
Thill et al. |
2006/0271171 |
November 2006 |
McQuinn et al. |
2006/0282150 |
December 2006 |
Olson et al. |
2006/0287719 |
December 2006 |
Rowe et al. |
2007/0016286 |
January 2007 |
Herrmann et al. |
2007/0016288 |
January 2007 |
Gurskis et al. |
2007/0027528 |
February 2007 |
Agnew |
2007/0027549 |
February 2007 |
Godin |
2007/0038293 |
February 2007 |
St. Goar et al. |
2007/0038295 |
February 2007 |
Case et al. |
2007/0043435 |
February 2007 |
Seguin |
2007/0055340 |
March 2007 |
Pryor |
2007/0056346 |
March 2007 |
Spenser et al. |
2007/0078510 |
April 2007 |
Ryan |
2007/0112422 |
May 2007 |
Dehdashtian |
2007/0118141 |
May 2007 |
Davidson |
2007/0162103 |
July 2007 |
Case et al. |
2007/0162107 |
July 2007 |
Haug et al. |
2007/0162111 |
July 2007 |
Fukamachi et al. |
2007/0173932 |
July 2007 |
Cali et al. |
2007/0197858 |
August 2007 |
Goldfarb et al. |
2007/0198077 |
August 2007 |
Cully et al. |
2007/0198097 |
August 2007 |
Zegdi |
2007/0213810 |
September 2007 |
Newhauser et al. |
2007/0213813 |
September 2007 |
Von Segesser et al. |
2007/0219630 |
September 2007 |
Chu |
2007/0225759 |
September 2007 |
Thommen et al. |
2007/0225760 |
September 2007 |
Moszner et al. |
2007/0233186 |
October 2007 |
Meng |
2007/0233237 |
October 2007 |
Krivoruchko |
2007/0239272 |
October 2007 |
Navia et al. |
2007/0239273 |
October 2007 |
Allen |
2007/0244546 |
October 2007 |
Francis |
2007/0255400 |
November 2007 |
Parravicini et al. |
2008/0004688 |
January 2008 |
Spenser et al. |
2008/0004697 |
January 2008 |
Lichtenstein et al. |
2008/0051703 |
February 2008 |
Thornton et al. |
2008/0065204 |
March 2008 |
Macoviak et al. |
2008/0071361 |
March 2008 |
Tuval et al. |
2008/0071363 |
March 2008 |
Tuval et al. |
2008/0071366 |
March 2008 |
Tuval |
2008/0071369 |
March 2008 |
Tuval et al. |
2008/0077235 |
March 2008 |
Kirson |
2008/0082083 |
April 2008 |
Forde et al. |
2008/0082159 |
April 2008 |
Tseng et al. |
2008/0082166 |
April 2008 |
Styrc et al. |
2008/0086164 |
April 2008 |
Rowe |
2008/0086204 |
April 2008 |
Rankin |
2008/0091261 |
April 2008 |
Long et al. |
2008/0097595 |
April 2008 |
Gabbay |
2008/0132989 |
June 2008 |
Snow et al. |
2008/0140003 |
June 2008 |
Bei et al. |
2008/0147182 |
June 2008 |
Righini et al. |
2008/0161910 |
July 2008 |
Revuelta et al. |
2008/0167705 |
July 2008 |
Agnew |
2008/0167714 |
July 2008 |
St. Goar et al. |
2008/0188929 |
August 2008 |
Schreck |
2008/0195200 |
August 2008 |
Vidlund et al. |
2008/0200980 |
August 2008 |
Robin et al. |
2008/0208328 |
August 2008 |
Antocci et al. |
2008/0208332 |
August 2008 |
Lamphere et al. |
2008/0221672 |
September 2008 |
Lamphere et al. |
2008/0234814 |
September 2008 |
Salahieh et al. |
2008/0243245 |
October 2008 |
Thambar et al. |
2008/0255580 |
October 2008 |
Hoffman et al. |
2008/0262609 |
October 2008 |
Gross et al. |
2008/0269879 |
October 2008 |
Sathe et al. |
2008/0281411 |
November 2008 |
Berreklouw |
2008/0294234 |
November 2008 |
Hartley et al. |
2009/0005863 |
January 2009 |
Goetz et al. |
2009/0036966 |
February 2009 |
O'Connor et al. |
2009/0054969 |
February 2009 |
Salahieh et al. |
2009/0082844 |
March 2009 |
Zacharias et al. |
2009/0088836 |
April 2009 |
Bishop et al. |
2009/0099554 |
April 2009 |
Forster et al. |
2009/0099650 |
April 2009 |
Bolduc et al. |
2009/0112159 |
April 2009 |
Slattery et al. |
2009/0125098 |
May 2009 |
Chuter |
2009/0157175 |
June 2009 |
Benichou |
2009/0163934 |
June 2009 |
Raschdorf, Jr. et al. |
2009/0171363 |
July 2009 |
Chocron |
2009/0177278 |
July 2009 |
Spence |
2009/0210052 |
August 2009 |
Forster et al. |
2009/0222081 |
September 2009 |
Linder et al. |
2009/0240320 |
September 2009 |
Tuval et al. |
2009/0241656 |
October 2009 |
Jacquemin |
2009/0259306 |
October 2009 |
Rowe |
2009/0264859 |
October 2009 |
Mas |
2009/0264994 |
October 2009 |
Saadat |
2009/0276040 |
November 2009 |
Rowe et al. |
2009/0281619 |
November 2009 |
Le et al. |
2009/0287304 |
November 2009 |
Dahlgren et al. |
2009/0299449 |
December 2009 |
Styrc |
2009/0306768 |
December 2009 |
Quadri et al. |
2009/0319037 |
December 2009 |
Rowe et al. |
2010/0022823 |
January 2010 |
Goldfarb et al. |
2010/0023117 |
January 2010 |
Yoganathan et al. |
2010/0023120 |
January 2010 |
Holecek et al. |
2010/0036479 |
February 2010 |
Hill et al. |
2010/0049313 |
February 2010 |
Alon et al. |
2010/0069852 |
March 2010 |
Kelley |
2010/0076548 |
March 2010 |
Konno |
2010/0100167 |
April 2010 |
Bortlein et al. |
2010/0114299 |
May 2010 |
Ben Muvhar et al. |
2010/0131054 |
May 2010 |
Tuval et al. |
2010/0137979 |
June 2010 |
Tuval et al. |
2010/0160958 |
June 2010 |
Clark |
2010/0161036 |
June 2010 |
Pintor et al. |
2010/0161042 |
June 2010 |
Maisano et al. |
2010/0174363 |
July 2010 |
Castro |
2010/0179643 |
July 2010 |
Shalev |
2010/0179648 |
July 2010 |
Richter et al. |
2010/0179649 |
July 2010 |
Richter et al. |
2010/0217382 |
August 2010 |
Chau et al. |
2010/0222810 |
September 2010 |
DeBeer et al. |
2010/0228285 |
September 2010 |
Miles et al. |
2010/0234940 |
September 2010 |
Dolan |
2010/0249908 |
September 2010 |
Chau et al. |
2010/0249917 |
September 2010 |
Zhang |
2010/0256737 |
October 2010 |
Pollock et al. |
2010/0262232 |
October 2010 |
Annest |
2010/0280603 |
November 2010 |
Maisano et al. |
2010/0280606 |
November 2010 |
Naor |
2010/0312333 |
December 2010 |
Navia et al. |
2010/0324595 |
December 2010 |
Linder et al. |
2010/0331971 |
December 2010 |
Keranen |
2011/0004227 |
January 2011 |
Goldfarb et al. |
2011/0004296 |
January 2011 |
Lutter et al. |
2011/0004299 |
January 2011 |
Navia et al. |
2011/0015729 |
January 2011 |
Carpentier et al. |
2011/0021985 |
January 2011 |
Spargias |
2011/0022165 |
January 2011 |
Oba et al. |
2011/0029072 |
February 2011 |
Gabbay |
2011/0040374 |
February 2011 |
Goetz et al. |
2011/0040375 |
February 2011 |
Letac et al. |
2011/0046662 |
February 2011 |
Moszner et al. |
2011/0054466 |
March 2011 |
Rothstein et al. |
2011/0054596 |
March 2011 |
Taylor |
2011/0054598 |
March 2011 |
Johnson |
2011/0066233 |
March 2011 |
Thornton et al. |
2011/0071626 |
March 2011 |
Wright et al. |
2011/0077730 |
March 2011 |
Fenster |
2011/0082538 |
April 2011 |
Dahlgren et al. |
2011/0087322 |
April 2011 |
Letac et al. |
2011/0093063 |
April 2011 |
Schreck |
2011/0098525 |
April 2011 |
Kermode et al. |
2011/0106247 |
May 2011 |
Miller et al. |
2011/0112625 |
May 2011 |
Ben-Muvhar et al. |
2011/0112632 |
May 2011 |
Chau et al. |
2011/0118830 |
May 2011 |
Liddicoat et al. |
2011/0125257 |
May 2011 |
Seguin et al. |
2011/0125258 |
May 2011 |
Centola |
2011/0137326 |
June 2011 |
Bachman |
2011/0137397 |
June 2011 |
Chau |
2011/0137409 |
June 2011 |
Yang et al. |
2011/0137410 |
June 2011 |
Hacohen |
2011/0144742 |
June 2011 |
Madrid et al. |
2011/0166636 |
July 2011 |
Rowe |
2011/0172784 |
July 2011 |
Richter et al. |
2011/0178597 |
July 2011 |
Navia et al. |
2011/0184510 |
July 2011 |
Maisano et al. |
2011/0190877 |
August 2011 |
Lane et al. |
2011/0190879 |
August 2011 |
Bobo et al. |
2011/0202076 |
August 2011 |
Richter |
2011/0208283 |
August 2011 |
Rust |
2011/0208293 |
August 2011 |
Tabor |
2011/0208298 |
August 2011 |
Tuval et al. |
2011/0213459 |
September 2011 |
Garrison et al. |
2011/0213461 |
September 2011 |
Seguin et al. |
2011/0218619 |
September 2011 |
Benichou et al. |
2011/0218620 |
September 2011 |
Meiri et al. |
2011/0224785 |
September 2011 |
Hacohen |
2011/0238159 |
September 2011 |
Guyenot et al. |
2011/0245911 |
October 2011 |
Quill et al. |
2011/0245917 |
October 2011 |
Savage et al. |
2011/0251675 |
October 2011 |
Dwork |
2011/0251676 |
October 2011 |
Sweeney et al. |
2011/0251678 |
October 2011 |
Eidenschink et al. |
2011/0251679 |
October 2011 |
Wiemeyer et al. |
2011/0251680 |
October 2011 |
Tran et al. |
2011/0251682 |
October 2011 |
Murray, III et al. |
2011/0251683 |
October 2011 |
Tabor |
2011/0257721 |
October 2011 |
Tabor |
2011/0257729 |
October 2011 |
Spenser et al. |
2011/0257736 |
October 2011 |
Marquez et al. |
2011/0257737 |
October 2011 |
Fogarty et al. |
2011/0264191 |
October 2011 |
Rothstein |
2011/0264196 |
October 2011 |
Savage et al. |
2011/0264198 |
October 2011 |
Murray, III et al. |
2011/0264199 |
October 2011 |
Tran et al. |
2011/0264200 |
October 2011 |
Tran et al. |
2011/0264201 |
October 2011 |
Yeung et al. |
2011/0264202 |
October 2011 |
Murray, III et al. |
2011/0264203 |
October 2011 |
Dwork et al. |
2011/0264206 |
October 2011 |
Tabor |
2011/0264208 |
October 2011 |
Duffy et al. |
2011/0270276 |
November 2011 |
Rothstein et al. |
2011/0271967 |
November 2011 |
Mortier et al. |
2011/0282438 |
November 2011 |
Drews et al. |
2011/0282439 |
November 2011 |
Thill et al. |
2011/0282440 |
November 2011 |
Cao et al. |
2011/0283514 |
November 2011 |
Fogarty et al. |
2011/0288632 |
November 2011 |
White |
2011/0288634 |
November 2011 |
Tuval et al. |
2011/0295354 |
December 2011 |
Bueche et al. |
2011/0295363 |
December 2011 |
Girard et al. |
2011/0301688 |
December 2011 |
Dolan |
2011/0301701 |
December 2011 |
Padala et al. |
2011/0301702 |
December 2011 |
Rust et al. |
2011/0306916 |
December 2011 |
Nitzan et al. |
2011/0307049 |
December 2011 |
Kao |
2011/0313452 |
December 2011 |
Carley et al. |
2011/0313515 |
December 2011 |
Quadri et al. |
2011/0319989 |
December 2011 |
Lane et al. |
2011/0319991 |
December 2011 |
Hariton et al. |
2012/0010694 |
January 2012 |
Lutter et al. |
2012/0016468 |
January 2012 |
Robin et al. |
2012/0022629 |
January 2012 |
Perera et al. |
2012/0022633 |
January 2012 |
Olson et al. |
2012/0022637 |
January 2012 |
Ben-Muvhar |
2012/0022639 |
January 2012 |
Hacohen et al. |
2012/0022640 |
January 2012 |
Gross et al. |
2012/0035703 |
February 2012 |
Lutter et al. |
2012/0035713 |
February 2012 |
Lutter et al. |
2012/0035722 |
February 2012 |
Tuval |
2012/0041547 |
February 2012 |
Duffy et al. |
2012/0041551 |
February 2012 |
Spenser et al. |
2012/0046738 |
February 2012 |
Lau et al. |
2012/0046742 |
February 2012 |
Tuval et al. |
2012/0053676 |
March 2012 |
Ku et al. |
2012/0053682 |
March 2012 |
Kovalsky et al. |
2012/0053688 |
March 2012 |
Fogarty et al. |
2012/0059454 |
March 2012 |
Millwee et al. |
2012/0059458 |
March 2012 |
Buchbinder et al. |
2012/0065464 |
March 2012 |
Ellis et al. |
2012/0078237 |
March 2012 |
Wang et al. |
2012/0078353 |
March 2012 |
Quadri et al. |
2012/0078357 |
March 2012 |
Conklin |
2012/0083832 |
April 2012 |
Delaloye et al. |
2012/0083839 |
April 2012 |
Letac et al. |
2012/0083879 |
April 2012 |
Eberhardt et al. |
2012/0089223 |
April 2012 |
Nguyen et al. |
2012/0101570 |
April 2012 |
Tuval et al. |
2012/0101571 |
April 2012 |
Thambar et al. |
2012/0101572 |
April 2012 |
Kovalsky et al. |
2012/0123511 |
May 2012 |
Brown |
2012/0123530 |
May 2012 |
Carpentier et al. |
2012/0130473 |
May 2012 |
Norris et al. |
2012/0130474 |
May 2012 |
Buckley |
2012/0130475 |
May 2012 |
Shaw |
2012/0136434 |
May 2012 |
Carpentier et al. |
2012/0150218 |
June 2012 |
Sandgren et al. |
2012/0165915 |
June 2012 |
Melsheimer et al. |
2012/0165930 |
June 2012 |
Gifford, III et al. |
2012/0179244 |
July 2012 |
Schankereli et al. |
2012/0197292 |
August 2012 |
Chin-Chen et al. |
2012/0283824 |
November 2012 |
Lutter et al. |
2012/0290062 |
November 2012 |
McNamara et al. |
2012/0296360 |
November 2012 |
Norris et al. |
2012/0296418 |
November 2012 |
Bonyuet et al. |
2012/0300063 |
November 2012 |
Majkrzak et al. |
2012/0310328 |
December 2012 |
Olson et al. |
2012/0323316 |
December 2012 |
Chau et al. |
2012/0330408 |
December 2012 |
Hillukkia et al. |
2013/0006347 |
January 2013 |
McHugo |
2013/0018450 |
January 2013 |
Hunt |
2013/0018458 |
January 2013 |
Yohanan et al. |
2013/0030519 |
January 2013 |
Tran et al. |
2013/0035759 |
February 2013 |
Gross et al. |
2013/0041451 |
February 2013 |
Patterson et al. |
2013/0046373 |
February 2013 |
Cartledge et al. |
2013/0066341 |
March 2013 |
Ketai et al. |
2013/0066342 |
March 2013 |
Dell et al. |
2013/0079872 |
March 2013 |
Gallagher |
2013/0116780 |
May 2013 |
Miller et al. |
2013/0123896 |
May 2013 |
Bloss et al. |
2013/0123900 |
May 2013 |
Eblacas et al. |
2013/0150945 |
June 2013 |
Crawford et al. |
2013/0150956 |
June 2013 |
Yohanan et al. |
2013/0158647 |
June 2013 |
Norris et al. |
2013/0166017 |
June 2013 |
Cartledge et al. |
2013/0166022 |
June 2013 |
Conklin |
2013/0172978 |
July 2013 |
Vidlund et al. |
2013/0172992 |
July 2013 |
Gross et al. |
2013/0178930 |
July 2013 |
Straubinger et al. |
2013/0190861 |
July 2013 |
Chau et al. |
2013/0211501 |
August 2013 |
Buckley et al. |
2013/0245742 |
September 2013 |
Norris |
2013/0253643 |
September 2013 |
Rolando et al. |
2013/0261737 |
October 2013 |
Costello |
2013/0261738 |
October 2013 |
Clague et al. |
2013/0274870 |
October 2013 |
Lombardi et al. |
2013/0282059 |
October 2013 |
Ketai et al. |
2013/0289711 |
October 2013 |
Liddy et al. |
2013/0289740 |
October 2013 |
Liddy et al. |
2013/0297013 |
November 2013 |
Klima et al. |
2013/0304197 |
November 2013 |
Buchbinder et al. |
2013/0304200 |
November 2013 |
McLean et al. |
2013/0310928 |
November 2013 |
Morriss et al. |
2013/0325114 |
December 2013 |
McLean et al. |
2013/0331929 |
December 2013 |
Mitra et al. |
2014/0000112 |
January 2014 |
Braido et al. |
2014/0005778 |
January 2014 |
Buchbinder et al. |
2014/0018911 |
January 2014 |
Zhou et al. |
2014/0018915 |
January 2014 |
Biadillah et al. |
2014/0031928 |
January 2014 |
Murphy et al. |
2014/0046430 |
February 2014 |
Shaw |
2014/0052237 |
February 2014 |
Lane et al. |
2014/0067050 |
March 2014 |
Costello et al. |
2014/0067054 |
March 2014 |
Chau et al. |
2014/0081376 |
March 2014 |
Burkart et al. |
2014/0106951 |
April 2014 |
Brandon |
2014/0120287 |
May 2014 |
Jacoby et al. |
2014/0121749 |
May 2014 |
Roeder |
2014/0121763 |
May 2014 |
Duffy et al. |
2014/0135894 |
May 2014 |
Norris et al. |
2014/0135895 |
May 2014 |
Andress et al. |
2014/0142681 |
May 2014 |
Norris |
2014/0142688 |
May 2014 |
Duffy et al. |
2014/0148891 |
May 2014 |
Johnson |
2014/0163690 |
June 2014 |
White |
2014/0172069 |
June 2014 |
Roeder et al. |
2014/0172077 |
June 2014 |
Bruchman et al. |
2014/0172082 |
June 2014 |
Bruchman et al. |
2014/0188210 |
July 2014 |
Beard et al. |
2014/0188221 |
July 2014 |
Chung et al. |
2014/0194981 |
July 2014 |
Menk et al. |
2014/0194983 |
July 2014 |
Kovalsky et al. |
2014/0207231 |
July 2014 |
Hacohen et al. |
2014/0214157 |
July 2014 |
Bortlein et al. |
2014/0214159 |
July 2014 |
Vidlund et al. |
2014/0222136 |
August 2014 |
Geist et al. |
2014/0222142 |
August 2014 |
Kovalsky et al. |
2014/0236287 |
August 2014 |
Clague et al. |
2014/0236289 |
August 2014 |
Alkhatib |
2014/0249622 |
September 2014 |
Carmi et al. |
2014/0257461 |
September 2014 |
Robinson et al. |
2014/0257467 |
September 2014 |
Lane et al. |
2014/0257475 |
September 2014 |
Gross et al. |
2014/0257476 |
September 2014 |
Montorfano et al. |
2014/0277358 |
September 2014 |
Slazas |
2014/0277409 |
September 2014 |
Bortlein et al. |
2014/0277411 |
September 2014 |
Bortlein et al. |
2014/0277418 |
September 2014 |
Miller |
2014/0277422 |
September 2014 |
Ratz et al. |
2014/0277427 |
September 2014 |
Ratz et al. |
2014/0296962 |
October 2014 |
Cartledge et al. |
2014/0296969 |
October 2014 |
Tegels et al. |
2014/0324164 |
October 2014 |
Gross et al. |
2014/0331475 |
November 2014 |
Duffy et al. |
2014/0336744 |
November 2014 |
Tani et al. |
2014/0343670 |
November 2014 |
Bakis et al. |
2014/0358222 |
December 2014 |
Gorman, III et al. |
2014/0358224 |
December 2014 |
Tegels et al. |
2014/0379065 |
December 2014 |
Johnson et al. |
2014/0379074 |
December 2014 |
Spence et al. |
2014/0379076 |
December 2014 |
Vidlund et al. |
2015/0018944 |
January 2015 |
O'Connell et al. |
2015/0032205 |
January 2015 |
Matheny |
2015/0045881 |
February 2015 |
Lim |
2015/0094802 |
April 2015 |
Buchbinder et al. |
2015/0119970 |
April 2015 |
Nakayama et al. |
2015/0127097 |
May 2015 |
Neumann et al. |
2015/0142100 |
May 2015 |
Morriss et al. |
2015/0142103 |
May 2015 |
Vidlund |
2015/0157458 |
June 2015 |
Tharnbar et al. |
2015/0164640 |
June 2015 |
McLean et al. |
2015/0173896 |
June 2015 |
Richter et al. |
2015/0173897 |
June 2015 |
Raanani et al. |
2015/0196390 |
July 2015 |
Ma et al. |
2015/0196393 |
July 2015 |
Vidlund et al. |
2015/0216661 |
August 2015 |
Hacohen et al. |
2015/0238313 |
August 2015 |
Spence et al. |
2015/0245934 |
September 2015 |
Lombardi et al. |
2015/0250588 |
September 2015 |
Yang et al. |
2015/0272730 |
October 2015 |
Melnick et al. |
2015/0272734 |
October 2015 |
Sheps et al. |
2015/0282964 |
October 2015 |
Beard et al. |
2015/0320556 |
November 2015 |
Levi et al. |
2015/0327994 |
November 2015 |
Morriss et al. |
2015/0328000 |
November 2015 |
Ratz et al. |
2015/0335429 |
November 2015 |
Morriss et al. |
2015/0351903 |
December 2015 |
Morriss et al. |
2015/0351904 |
December 2015 |
Cooper et al. |
2015/0359629 |
December 2015 |
Ganesan et al. |
2016/0008129 |
January 2016 |
Siegel |
2016/0030169 |
February 2016 |
Shahriari |
2016/0030171 |
February 2016 |
Quijano et al. |
2016/0089482 |
March 2016 |
Siegenthaler |
2016/0095700 |
April 2016 |
Righini |
2016/0100939 |
April 2016 |
Armstrong et al. |
2016/0106539 |
April 2016 |
Buchbinder et al. |
2016/0113766 |
April 2016 |
Ganesan et al. |
2016/0113768 |
April 2016 |
Ganesan et al. |
2016/0125160 |
May 2016 |
Heneghan et al. |
2016/0175095 |
June 2016 |
Dienno et al. |
2016/0220367 |
August 2016 |
Barrett |
2016/0228247 |
August 2016 |
Maimon et al. |
2016/0242902 |
August 2016 |
Morriss et al. |
2016/0270911 |
September 2016 |
Ganesan et al. |
2016/0310268 |
October 2016 |
Oba et al. |
2016/0310274 |
October 2016 |
Gross et al. |
2016/0317301 |
November 2016 |
Quadri et al. |
2016/0317305 |
November 2016 |
Pelled et al. |
2016/0324633 |
November 2016 |
Gross et al. |
2016/0324635 |
November 2016 |
Vidlund et al. |
2016/0324640 |
November 2016 |
Gifford, III et al. |
2016/0331526 |
November 2016 |
Schweich, Jr. et al. |
2016/0331527 |
November 2016 |
Vidlund et al. |
2016/0338706 |
November 2016 |
Rowe |
2016/0367360 |
December 2016 |
Cartledge et al. |
2016/0367368 |
December 2016 |
Vidlund et al. |
2016/0374801 |
December 2016 |
Jimenez et al. |
2016/0374802 |
December 2016 |
Levi et al. |
2017/0042678 |
February 2017 |
Ganesan et al. |
2017/0049435 |
February 2017 |
Sauer et al. |
2017/0056166 |
March 2017 |
Ratz et al. |
2017/0056171 |
March 2017 |
Cooper et al. |
2017/0065411 |
March 2017 |
Grundeman et al. |
2017/0100236 |
April 2017 |
Robertson et al. |
2017/0128205 |
May 2017 |
Tamir et al. |
2017/0135816 |
May 2017 |
Lashinski et al. |
2017/0189174 |
July 2017 |
Braido et al. |
2017/0196688 |
July 2017 |
Christianson et al. |
2017/0196692 |
July 2017 |
Kirk et al. |
2017/0209264 |
July 2017 |
Chau et al. |
2017/0216026 |
August 2017 |
Quill et al. |
2017/0224323 |
August 2017 |
Rowe et al. |
2017/0231757 |
August 2017 |
Gassler |
2017/0231759 |
August 2017 |
Geist et al. |
2017/0231760 |
August 2017 |
Lane et al. |
2017/0239048 |
August 2017 |
Goldfarb et al. |
2017/0333183 |
November 2017 |
Backus |
2017/0333187 |
November 2017 |
Hariton et al. |
2018/0000580 |
January 2018 |
Wallace et al. |
2018/0014930 |
January 2018 |
Hariton et al. |
2018/0021129 |
January 2018 |
Peterson et al. |
2018/0028215 |
February 2018 |
Cohen |
2018/0049873 |
February 2018 |
Manash et al. |
2018/0055628 |
March 2018 |
Patel et al. |
2018/0055630 |
March 2018 |
Patel et al. |
2018/0098850 |
April 2018 |
Rafiee et al. |
2018/0116790 |
May 2018 |
Ratz et al. |
2018/0116843 |
May 2018 |
Schreck et al. |
2018/0125644 |
May 2018 |
Conklin |
2018/0132999 |
May 2018 |
Perouse |
2018/0153689 |
June 2018 |
Maimon et al. |
2018/0161159 |
June 2018 |
Lee et al. |
2018/0177594 |
June 2018 |
Patel et al. |
2018/0206983 |
July 2018 |
Noe et al. |
2018/0214263 |
August 2018 |
Rolando et al. |
2018/0243086 |
August 2018 |
Barbarino et al. |
2018/0250126 |
September 2018 |
O'connor et al. |
2018/0250147 |
September 2018 |
Syed |
2018/0296333 |
October 2018 |
Dixon et al. |
2018/0296336 |
October 2018 |
Cooper et al. |
2018/0296341 |
October 2018 |
Noe et al. |
2018/0344457 |
December 2018 |
Gross et al. |
2018/0353294 |
December 2018 |
Calomeni et al. |
2018/0360457 |
December 2018 |
Ellis et al. |
2019/0000613 |
January 2019 |
Delgado et al. |
2019/0015200 |
January 2019 |
Delgado et al. |
2019/0021852 |
January 2019 |
Delgado et al. |
2019/0053896 |
February 2019 |
Adamek-bowers et al. |
2019/0060060 |
February 2019 |
Chau et al. |
2019/0060068 |
February 2019 |
Cope et al. |
2019/0060070 |
February 2019 |
Groothuis et al. |
2019/0069997 |
March 2019 |
Ratz et al. |
2019/0083261 |
March 2019 |
Perszyk et al. |
2019/0105153 |
April 2019 |
Barash et al. |
2019/0117391 |
April 2019 |
Humair |
2019/0167423 |
June 2019 |
Hariton et al. |
2019/0175339 |
June 2019 |
Vidlund |
2019/0183639 |
June 2019 |
Moore |
2019/0192295 |
June 2019 |
Spence et al. |
2019/0216602 |
July 2019 |
Lozonschi |
2019/0336280 |
November 2019 |
Naor |
2019/0350701 |
November 2019 |
Adamek-bowers et al. |
2019/0365530 |
December 2019 |
Hoang et al. |
2019/0388218 |
December 2019 |
Vidlund et al. |
2019/0388220 |
December 2019 |
Vidlund et al. |
2020/0000449 |
January 2020 |
Goldfarb et al. |
2020/0000579 |
January 2020 |
Manash et al. |
2020/0015964 |
January 2020 |
Noe et al. |
2020/0030098 |
January 2020 |
Delgado et al. |
2020/0054335 |
February 2020 |
Hemandez et al. |
2020/0060818 |
February 2020 |
Geist et al. |
2020/0113677 |
April 2020 |
McCann et al. |
2020/0113689 |
April 2020 |
McCann et al. |
2020/0113692 |
April 2020 |
McCann et al. |
2020/0138567 |
May 2020 |
Marr et al. |
2020/0163761 |
May 2020 |
Hariton et al. |
2020/0214832 |
July 2020 |
Metchik et al. |
2020/0237512 |
July 2020 |
McCann et al. |
2020/0246136 |
August 2020 |
Marr et al. |
2020/0246140 |
August 2020 |
Hariton et al. |
2020/0253600 |
August 2020 |
Darabian |
2020/0261094 |
August 2020 |
Goldfarb et al. |
2020/0315786 |
October 2020 |
Metchik et al. |
2020/0337842 |
October 2020 |
Metchik et al. |
2021/0093449 |
April 2021 |
Hariton et al. |
2021/0113331 |
April 2021 |
Quadri et al. |
2021/0137680 |
May 2021 |
Kizuka et al. |
2021/0259835 |
August 2021 |
Tyler, II et al. |
|
Foreign Patent Documents
|
|
|
|
|
|
|
2822801 |
|
Aug 2006 |
|
CA |
|
103974674 |
|
Aug 2014 |
|
CN |
|
1264582 |
|
Nov 2002 |
|
EP |
|
1637092 |
|
Mar 2006 |
|
EP |
|
1768630 |
|
Jan 2015 |
|
EP |
|
2349124 |
|
Oct 2018 |
|
EP |
|
3583922 |
|
Dec 2019 |
|
EP |
|
3270825 |
|
Apr 2020 |
|
EP |
|
2485795 |
|
Sep 2020 |
|
EP |
|
S53152790 |
|
Dec 1978 |
|
JP |
|
2001-0046894 |
|
Jun 2001 |
|
KR |
|
98/43557 |
|
Oct 1998 |
|
WO |
|
99/30647 |
|
Jun 1999 |
|
WO |
|
00/47139 |
|
Aug 2000 |
|
WO |
|
01/62189 |
|
Aug 2001 |
|
WO |
|
01/82832 |
|
Nov 2001 |
|
WO |
|
01/87190 |
|
Nov 2001 |
|
WO |
|
2003/020179 |
|
Mar 2003 |
|
WO |
|
03/28558 |
|
Apr 2003 |
|
WO |
|
2004/028399 |
|
Apr 2004 |
|
WO |
|
2005/107650 |
|
Nov 2005 |
|
WO |
|
2006/007389 |
|
Jan 2006 |
|
WO |
|
2006/007401 |
|
Jan 2006 |
|
WO |
|
2006/054930 |
|
Jul 2006 |
|
WO |
|
2006/070372 |
|
Jul 2006 |
|
WO |
|
2006/086434 |
|
Aug 2006 |
|
WO |
|
2006/089236 |
|
Aug 2006 |
|
WO |
|
2006/116558 |
|
Nov 2006 |
|
WO |
|
2006/128193 |
|
Nov 2006 |
|
WO |
|
2007/047488 |
|
Apr 2007 |
|
WO |
|
207/059252 |
|
May 2007 |
|
WO |
|
2008/013915 |
|
Jan 2008 |
|
WO |
|
2008/029296 |
|
Mar 2008 |
|
WO |
|
2008/070797 |
|
Jun 2008 |
|
WO |
|
2008/103722 |
|
Aug 2008 |
|
WO |
|
2009/033469 |
|
Mar 2009 |
|
WO |
|
2009/053497 |
|
Apr 2009 |
|
WO |
|
2009091509 |
|
Jul 2009 |
|
WO |
|
2010/006627 |
|
Jan 2010 |
|
WO |
|
2010/027485 |
|
Mar 2010 |
|
WO |
|
2010/037141 |
|
Apr 2010 |
|
WO |
|
2010/045297 |
|
Apr 2010 |
|
WO |
|
2010/057262 |
|
May 2010 |
|
WO |
|
2010/073246 |
|
Jul 2010 |
|
WO |
|
2010/081033 |
|
Jul 2010 |
|
WO |
|
2010/121076 |
|
Oct 2010 |
|
WO |
|
2011/025972 |
|
Mar 2011 |
|
WO |
|
2011/069048 |
|
Jun 2011 |
|
WO |
|
2011/106137 |
|
Sep 2011 |
|
WO |
|
2011/111047 |
|
Sep 2011 |
|
WO |
|
2011/137531 |
|
Nov 2011 |
|
WO |
|
2011/143263 |
|
Nov 2011 |
|
WO |
|
2011/144351 |
|
Nov 2011 |
|
WO |
|
2011/154942 |
|
Dec 2011 |
|
WO |
|
2012/011108 |
|
Jan 2012 |
|
WO |
|
2012/024428 |
|
Feb 2012 |
|
WO |
|
2012/036740 |
|
Mar 2012 |
|
WO |
|
2012/048035 |
|
Apr 2012 |
|
WO |
|
2012/127309 |
|
Sep 2012 |
|
WO |
|
2012/177942 |
|
Dec 2012 |
|
WO |
|
2013/021374 |
|
Feb 2013 |
|
WO |
|
2013/021375 |
|
Feb 2013 |
|
WO |
|
2013/021384 |
|
Feb 2013 |
|
WO |
|
2013/059747 |
|
Apr 2013 |
|
WO |
|
2013/072496 |
|
May 2013 |
|
WO |
|
2013/078497 |
|
Jun 2013 |
|
WO |
|
2013/128436 |
|
Jun 2013 |
|
WO |
|
2013/114214 |
|
Aug 2013 |
|
WO |
|
2013/175468 |
|
Nov 2013 |
|
WO |
|
2014/022124 |
|
Feb 2014 |
|
WO |
|
2014/076696 |
|
May 2014 |
|
WO |
|
2014/115149 |
|
Jul 2014 |
|
WO |
|
2014/144937 |
|
Sep 2014 |
|
WO |
|
2014/145338 |
|
Sep 2014 |
|
WO |
|
2014/164364 |
|
Oct 2014 |
|
WO |
|
2014/194178 |
|
Dec 2014 |
|
WO |
|
2015/173794 |
|
Nov 2015 |
|
WO |
|
2016/016899 |
|
Feb 2016 |
|
WO |
|
2016/093877 |
|
Jun 2016 |
|
WO |
|
2016/125160 |
|
Aug 2016 |
|
WO |
|
2017/223486 |
|
Dec 2017 |
|
WO |
|
2018/025260 |
|
Feb 2018 |
|
WO |
|
2018/025263 |
|
Feb 2018 |
|
WO |
|
2018/039631 |
|
Feb 2018 |
|
WO |
|
2018/039631 |
|
Mar 2018 |
|
WO |
|
2018/106837 |
|
Jun 2018 |
|
WO |
|
2018/112429 |
|
Jun 2018 |
|
WO |
|
2018/118717 |
|
Jun 2018 |
|
WO |
|
2018/131042 |
|
Jul 2018 |
|
WO |
|
2018/131043 |
|
Jul 2018 |
|
WO |
|
2019/026059 |
|
Feb 2019 |
|
WO |
|
2019/027507 |
|
Feb 2019 |
|
WO |
|
2019/030753 |
|
Feb 2019 |
|
WO |
|
2019/077595 |
|
Apr 2019 |
|
WO |
|
2019/116369 |
|
Jun 2019 |
|
WO |
|
2019/138400 |
|
Jul 2019 |
|
WO |
|
2019/195860 |
|
Oct 2019 |
|
WO |
|
2019/202579 |
|
Oct 2019 |
|
WO |
|
2020/058972 |
|
Mar 2020 |
|
WO |
|
2020/167677 |
|
Aug 2020 |
|
WO |
|
Other References
ISR and WO mailed Feb. 6, 2013; PCT/IL2012/00292. cited by
applicant .
ISR and WO mailed Feb. 6, 2013; PCT/IL2012/000293. cited by
applicant .
ISR and WO mailed Sep. 4, 2014 PCT/IL2014/050087. cited by
applicant .
ISR and WO mailed Oct. 27, 2015; PCT/IL2015/050792. cited by
applicant .
ISR and WO mailed May 30, 2016; PCT/IL2016/050125. cited by
applicant .
Alexander Geha, et al; "Replacement of Degenerated Mitral and
Aortic Bioprostheses Without Explantation", Ann. Thorac. Surg. Jun.
2001, 72: 1509-1514. cited by applicant .
Dominique Himbert MD; Mitral Regurgitation and Stenosis from
Bioprosthesis and Annuloplasty Failure: Transcatheter Approaches
and Outcomes:, 24 pages, Oct. 28, 2013. cited by applicant .
Saturn Project; "A Novel Solution for Transcatheter Heart Valve
Replacement Specifically Designed to Address Clinical Therapeutic
Needs on Mitral Valve", Dec. 2016; 8 pages. cited by applicant
.
Frank Langer MD et al; "Ring plus String; Papillary Muscle
Repositioning as an Adjunctive Repair Technique for Ischemic Mitral
Regurgitation", J. Thoracic Cardiovasc. Surg. 133: 247-9, Jan.
2007. cited by applicant .
Frank Langer MD et al; "Ring+String Successful Repair Technique for
ischemic Mitral Regurgitation With Severe Leaflet Tethering",
Circulation 120[suppl 1]; S85-S91, Sep. 2009. cited by applicant
.
Francesco Maisano MD; Valvetech Cardiovalve: Novel Design Feature
and Clinical Update, 2015; TCR Presentation re Cardiovalve; 10
pages. cited by applicant .
Giovanni Righini; Righini presentation EuroPCR May 2015
(Saturn)-(downloaded from:
https://www.pcronline.com/Cases-resourcesimages/Resources/Course-videos-s-
lides/2015/Cardiovascularinnovation-pipeline-Mitral-and-tricuspid-valve-in-
terventions). cited by applicant .
John G. Webb, et al; "Transcatheter Valve-in-Valve Implantation for
Failed Bioprosthetic Heart Valves", Circulation 2010; 1121;
1848-1847, originally published online Apr. 12, 2010. cited by
applicant .
S. Willeke, et al; Detachable shape-memory sewing ring for heart
valves:, Artificial Organs, 16: 294-297; 1992 (an abstract). cited
by applicant .
U.S. Appl. No. 61/283,819. cited by applicant .
U.S. Appl. No. 61/492,449 cited by applicant .
U.S. Appl. No. 61/515,372. cited by applicant .
U.S. Appl. No. 61/525,281. cited by applicant .
U.S. Appl. No. 61/537,276. cited by applicant .
U.S. Appl. No. 61/555,160. cited by applicant .
U.S. Appl. No. 61/588,892. cited by applicant .
USPTO NFOA dated Oct. 23, 2017 in connection with U.S. Appl. No.
14/763,004. cited by applicant .
USPTO FOA dated Jan. 17, 2018 in connection with U.S. Appl. No.
14/763,004. cited by applicant .
USPTO NFOA dated Feb. 27, 2018 in connection with U.S. Appl. No.
15/197,069. cited by applicant .
USPTO NFOA dated Dec. 7, 2017 in connection with U.S. Appl. No.
15/213,791. cited by applicant .
USPTO Interview Summary dated Feb. 8, 2018 in connection with U.S.
Appl. No. 15/213,791. cited by applicant .
USPTO NFOA dated Jan. 5, 2018 in connection with U.S. Appl. No.
15/541,783. cited by applicant .
USPTO NFOA dated Feb. 2, 2018 in connection with U.S. Appl. No.
15/329,920. cited by applicant .
Invitation to pay additional fees dated Jan. 2, 2018;
PCT/IL2017/050849. cited by applicant .
IPRP issued Feb. 5, 2019; PCT/IL2017/050849. cited by applicant
.
IPRP issued Feb. 12, 2019; PCT/IL2017/050873. cited by applicant
.
ISR and WO mailed Dec. 5, 2018; PCT/IL2018/050725. cited by
applicant .
ISR and WO mailed Nov. 9, 2018; PCT/IL2018/050869. cited by
applicant .
ISR and WO mailed Jan. 25, 2019; PCT/IL2018/051122. cited by
applicant .
ISR and WO mailed May 13, 2019: PCT/IL2018/051350. cited by
applicant .
ISR and WO mailed Apr. 25, 2019; PCT/IL2019/050142. cited by
applicant .
EPO OA dated Mar. 25, 2019; Appln. No. 14710060.6. cited by
applicant .
USPTO FOA dated Mar. 4, 2019 in connection with U.S. Appl. No.
14/763,004. cited by applicant .
USPTO FOA dated Jan. 30, 2019 in connection with U.S. Appl. No.
15/872,501. cited by applicant .
USPTO FOA dated Feb. 5, 2019 in connection with U.S. Appl. No.
15/899,858. cited by applicant .
USPTO NFOA dated Oct. 25, 2018 in connection with U.S. Appl. No.
14/763,004. cited by applicant .
USPTO NFOA dated Jan. 9, 2019 in connection with U.S. Appl. No.
15/329,920. cited by applicant .
USPTO NFOA dated May 23, 2019 in connection with U.S. Appl. No.
15/668,659. cited by applicant .
EESR dated Sep. 26, 2018; Appln. No. 1816784.7. cited by applicant
.
First Chinese Office Action dated Nov. 5, 2018; Appln. No.
201680008328.5. cited by applicant .
Invite to pay additional fees dated Oct. 11, 2018;
PCTI/IL2018/050725. cited by applicant .
USPTO NFOA dated Dec. 4, 2018 in connection with U.S. Appl. No.
16/045,059. cited by applicant .
USPTO NOA mailed Sep. 25, 2018 in connection with U.S. Appl. No.
15/188,507. cited by applicant .
USPTO FOA dated Feb. 10, 2014 in connection with U.S. Appl. No.
13/033,852. cited by applicant .
USPTO FOA dated Feb. 15, 2013 in connection with U.S. Appl. No.
12/840,463. cited by applicant .
USPTO FOA dated Feb. 25, 2016 in connection with U.S. Appl. No.
14/522,987. cited by applicant .
USPTO FOA dated Mar. 25, 2015 in connection with U.S. Appl. No.
12/840,463. cited by applicant .
USPTO FOA dated Apr. 13, 2016 in connection with U.S. Appl. No.
14/626,267. cited by applicant .
USPTO FOA dated May 23, 2014 in connection with U.S. Appl. No.
13/412,814. cited by applicant .
USPTO FOA dated Jul. 18, 2013 in connection with U.S. Appl. No.
13/044,694. cited by applicant .
USPTO FOA dated Jul. 23, 2013 in connection with U.S. Appl. No.
12/961,721. cited by applicant .
USPTO FOA dated Sep. 12, 2013 in connection with U.S. Appl. No.
13/412,814. cited by applicant .
USPTO NFOA dated Jan. 18, 2017 in connection with U.S. Appl. No.
14/626,267. cited by applicant .
USPTO NFOA dated Jan. 21, 2016 in connection with U.S. Appl. No.
14/237,264. cited by applicant .
USPTO NFOA dated Feb. 6, 2013 in connection with U.S. Appl. No.
13/412,814. cited by applicant .
USPTO NFOA dated Feb. 7, 2017 in connection with U.S. Appl. No.
14/689,608. cited by applicant .
An International Preliminary Report on Patentability dated Oct. 20,
2020, which issued during the prosecution of Applicants
PCT/IL2019/050142. cited by applicant .
An Office Action dated Oct. 5, 2020, which issued during the
prosecution of Canadian Patent Application No. 2,973,940. cited by
applicant .
Notice of Allowance dated Nov. 19, 2020, which issued during the
prosecution of U.S. Appl. No. 16/318,025. cited by applicant .
An Office Action dated Sep. 24, 2020, which issued during the
prosecution of U.S. Appl. No. 16/811,732. cited by applicant .
An Office Action summarized English translation and Search Report
dated Nov. 25, 2020, which issued during the prosecution of Chinese
Patent Application No. 201910449820.1. cited by applicant .
An Office Action dated Nov. 30, 2020, which issued during the
prosecution of U.S. Appl. No. 16/138,129. cited by applicant .
USPTO NFOA dated Jun. 4, 2014 in connection with U.S. Appl. No.
12/840,463. cited by applicant .
USPTO NFOA dated Jun. 17, 2014 in connection with U.S. Appl. No.
12/961,721. cited by applicant .
USPTO NFOA dated Jun. 30, 2015 in connection with U.S. Appl. No.
14/522,987. cited by applicant .
USPTO NFOA dated Jul. 2, 2014 in connection with U.S. Appl. No.
13/811,308. cited by applicant .
USPTO NFOA dated Jul. 3, 2014 in connection with U.S. Appl. No.
13/033,852. cited by applicant .
USPTO NFOA dated Aug. 2, 2013 in connection with U.S. Appl. No.
13/033,852. cited by applicant .
USPTO NFOA dated Sep. 19, 2014 in connection with U.S. Appl. No.
13/044,694. cited by applicant .
USPTO NFOA dated Nov. 8, 2013 in connection with U.S. Appl. No.
12/840,463. cited by applicant .
USPTO NFOA dated Nov. 23, 2012 in connection with U.S. Appl. No.
13/033,852. cited by applicant .
USPTO NFOA dated Nov. 27, 2015 in connection with U.S. Appl. No.
14/626,267. cited by applicant .
USPTO NFOA dated Nov. 28, 2012 in connection with U.S. Appl. No.
12/961,721. cited by applicant .
USPTO NFOA dated Dec. 10, 2015 in connection with U.S. Appl. No.
14/237,258. cited by applicant .
USPTO NFOA dated Dec. 31, 2012 in connection with U.S. Appl. No.
13/044,694. cited by applicant .
USPTO NFOA dated May 29, 2012 in connection with U.S. Appl. No.
12/840,463. cited by applicant .
USPTO NOA dated May 20, 2016 in connection with U.S. Appl. No.
14/237,258. cited by applicant .
USPTO NOA dated Jul. 6, 2017 in connection with U.S. Appl. No.
14/689,608. cited by applicant .
USPTO NOA dated Aug. 18, 2017 in connection with U.S. Appl. No.
14/689,608. cited by applicant .
USPTO NOA mailed Feb. 11, 2015 in connection with U.S. Appl. No.
13/033,852. cited by applicant .
USPTO NOA mailed Mar. 10, 2015 in connection with U.S. Appl. No.
13/811,308. cited by applicant .
USPTO NOA mailed Apr. 8, 2016 in connection with U.S. Appl. No.
14/237,258. cited by applicant .
USPTO NOA mailed May 5, 2015 in connection with U.S. Appl. No.
12/840,463. cited by applicant .
USPTO NOA dated May 10, 2016 in connection with U.S. Appl. No.
14/237,258. cited by applicant .
USPTO NOA mailed May 22, 2017 in connection with U.S. Appl. No.
14/689,608. cited by applicant .
USPTO NOA mailed Aug. 15, 2014 in connection with U.S. Appl. No.
13/412,814. cited by applicant .
USPTO RR dated Jan. 20, 2016 in connection with U.S. Appl. No.
14/161/921. cited by applicant .
USPTO RR dated Feb. 3, 2014 in connection with U.S. Appl. No.
13/811,308. cited by applicant .
USPTO RR dated Apr. 21, 2017 in connection with U.S. Appl. No.
15/213,791. cited by applicant .
USPTO RR dated Jul. 2, 2012 in connection with U.S. Appl. No.
13/033,852. cited by applicant .
USPTO RR dated Aug. 13, 2012 in connection with U.S. Appl. No.
13/044,694. cited by applicant .
USPTO RR dated Aug. 14, 2012 in connection with U.S. Appl. No.
12/961,721. cited by applicant .
USPTO RR dated Aug. 28, 2015 in connection with U.S. Appl. No.
14/237,264. cited by applicant .
USPTO RR dated Sep. 26, 2016 in connection with U.S. Appl. No.
14/763,004. cited by applicant .
Invitation to pay Additional Fees dated Jun. 12, 2014;
PCT/IL2014/050087. cited by applicant .
Invitation to pay Additional Fees dated Sep. 29, 2017;
PCT/IL2017/050873. cited by applicant .
EESR dated Jun. 29, 2017; Appln. No. 11809374.9. cited by applicant
.
EESR dated Feb. 18, 2015; Appln. No. 12821522.5. cited by applicant
.
EPO Office Action dated Feb. 10, 2017; Appln. No. 12821522.5. cited
by applicant .
UK Office Action dated Feb. 7, 2017; Appln. GB1613219.3. cited by
applicant .
IPRP issued Dec. 2, 2013; PCT/IL2011/000582. cited by applicant
.
IPRP issued Sep. 11, 2012; PCT/IL2011/000231. cited by applicant
.
IPRP issued Feb. 11, 2014; PCT/IL2012/000292. cited by applicant
.
IPRP issued Feb. 11, 2014 PCT/IL2012/000293. cited by applicant
.
ISR and WO mailed Dec. 5, 2011; PCT/IL11/00582. cited by applicant
.
ISR and WO mailed Mar. 17, 2014; PCT/IL13/50937. cited by applicant
.
ISR and WO mailed Oct. 13, 2011; PCT/IL11/00231. cited by applicant
.
An Office Action dated Jun. 25, 2019, which issued during the
prosecution of U.S. Appl. No. 15/329,920. cited by applicant .
An Office Action dated May 16, 2019, which issued during the
prosecution of U.S. Appl. No. 15/433,547. cited by applicant .
An Office Action dated Aug. 1, 2019, which issued during the
prosecution of U.S. Appl. No. 15/668,559. cited by applicant .
An Office Action dated Aug. 16, 2019, which issued during the
prosecution of U.S. Appl. No. 15/668,659. cited by applicant .
An Office Action dated Jun. 19, 2019, which issued during the
prosecution of U.S. Appl. No. 15/682,789. cited by applicant .
An Office Action dated Jun. 14, 2019, which issued during the
prosecution of U.S. Appl. No. 15/703,385. cited by applicant .
An Office Action dated Oct. 4, 2019, which issued during the
prosecution of U.S. Appl. No. 16/183,140. cited by applicant .
An Office Action dated Jun. 13, 2019, which issued during the
prosecution of U.S. Appl. No. 16/388,038. cited by applicant .
An Office Action dated Sep. 13, 2019, which issued during the
prosecution of U.S. Appl. No. 16/460,313. cited by applicant .
An Office Action dated Nov. 26, 2019, which issued during the
prosecution of U.S. Appl. No. 16/532,945. cited by applicant .
An Office Action dated Nov. 1, 2019, which issued during the
prosecution of U.S. Appl. No. 15/872,501. cited by applicant .
U.S. Appl. No. 14/689,608, filed Apr. 17, 2015, published as
2015/0216661, issued as U.S. Pat. No. 9,763,657. cited by applicant
.
U.S. Appl. No. 15/691,032, filed Aug. 30, 2017, published as
2017/0360426, issued as U.S. Pat. No. 10,512,456. cited by
applicant .
U.S. Appl. No. 61/492,449, filed Jun. 2, 2011. cited by applicant
.
U.S. Appl. No. 12/840,463, filed Jul. 21, 2010, published as
2012/0022639, issued as U.S. Pat. No. 9,132,009. cited by applicant
.
U.S. Appl. No. 13/033,852, filed Feb. 24, 2011, published as
2012/0022640, issued as U.S. Pat. No. 8,992,604. cited by applicant
.
U.S. Appl. No. 13/811,308, filed Mar. 7, 2013, published as
2013/0172992, issued as U.S. Pat. No. 9,017,399. cited by applicant
.
Notice of Allowance dated May 7, 2020, which issued during the
prosecution of U.S. Appl. No. 16/637,166. cited by applicant .
Sundermann, Simon H., et al. "Feasibility of the Engager.TM. aortic
transcatheter valve system using a flexible over-the-wire design."
European Journal of Cardio-Thoracic Surgery 42.4 (2012): e48-e52.
cited by applicant .
An Office Action summarized English translation and Search Report
dated Jul. 3, 2020, which issued during the prosecution of Chinese
Patent Application No. 201780061210.3. cited by applicant .
Serruys, P. W., Piazza, N., Cribier, A., Webb, J., Laborde, J. C.,
& de Jaegere, P. (Eds.). (2009). Transcatheter aortic valve
implantation: tips and tricks to avoid failure. CRC
Press.--Screenshots from Google Books downloaded from:
https://books.google.co.il/books?id=FLzLBQAAQBAJ&Ipg=PA198&ots=soqWrDH-y_-
&dq=%20%22Edwards%20SAPIEN%22&Ir&pg=PA20#v=onepage&q=%22Edwards%20SAPIEN%2-
2&f=false ; Downloaded on Jun. 18, 2020. cited by applicant
.
An International Search Report and a Written Opinion both dated
Jun. 24, 2020, which issued during the prosecution of Applicant's
PCT/IL2019/051398. cited by applicant .
An Office Action dated Jul. 14, 2020, which issued during the
prosecution of U.S. Appl. No. 16/324,339. cited by applicant .
Notice of Allowance dated Aug. 28, 2020, which issued during the
prosecution of U.S. Appl. No. 16/324,339. cited by applicant .
Notice of Allowance dated Jul. 29, 2020, which issued during the
prosecution of U.S. Appl. No. 16/132,937. cited by applicant .
An Office Action dated Jul. 29, 2020, which issued during the
prosecution of U.S. Appl. No. 16/269,328. cited by applicant .
Notice of Allowance dated Aug. 26, 2020, which issued during the
prosecution of U.S. Appl. No. 16/269,328. cited by applicant .
An Office Action dated Aug. 7, 2020, which issued during the
prosecution of U.S. Appl. No. 15/668,659. cited by applicant .
Tchetche, D. and Nicolas M. Van Mieghem: "New-generation TAVI
devices: description and specifications" EuroIntervention, 2014,
No. 10:U90-U100. cited by applicant .
Symetis S.A.: "Acurate neo.TM. Aortic Bioprosthesis for
Implantation using the ACURATE neo.TM. TA Transapical Delivery
System in Patients with Severe Aortic Stenosis," Clinical
Investigation Plan, Protocol No. 2015-01, Vs. No. 2, 2015:1-76.
cited by applicant .
Notice of Allowance dated Sep. 10, 2020, which issued during the
prosecution of U.S. Appl. No. 15/600,190. cited by applicant .
An Office Action dated Jan. 6, 2020, which issued during the
prosecution of U.S. Appl. No. 16/660,231. cited by applicant .
An Office Action dated Dec. 31, 2019, which issued during the
prosecution of U.S. Appl. No. 16/183,140. cited by applicant .
An Office Action dated Jan. 14, 2020, which issued during the
prosecution of U.S. Appl. No. 16/284,331. cited by applicant .
Notice of Allowance dated Jan. 13, 2020, which issued during the
prosecution of U.S. Appl. No. 15/956,956. cited by applicant .
European Search European Search Report dated Mar. 5, 2020 which
issued during the prosecution of Applicant's European App No.
17752184.6. cited by applicant .
European Search Report dated Mar. 4, 2020 which issued during the
prosecution of Applicant's European App No. 16706913.7. cited by
applicant .
Notice of Allowance dated Mar. 12, 2020, which issued during the
prosecution of U.S. Appl. No. 16/460,313. cited by applicant .
An Office Action dated Jan. 9, 2020, which issued during the
prosecution of U.S. Appl. No. 15/600,190. cited by applicant .
An Office Action dated Jan. 3, 2020, which issued during the
prosecution of U.S. Appl. No. 16/678,355. cited by applicant .
An Office Action dated Feb. 6, 2020, which issued during the
prosecution of U.S. Appl. No. 15/668,659. cited by applicant .
Poirier, Nancy C., et al. "A novel repair for patients with
atrioventricular septal defect requiring reoperation for left
atrioventricular valve regurgitation." European journal of
cardio-thoracic surgery 18.1 (2000): 54-61. cited by applicant
.
An Office Action dated Mar. 29, 2021, which issued during the
prosecution of U.S. Appl. No. 16/738,516. cited by applicant .
Ando, Tomo, et al. "Iatrogenic ventricular septal defect following
transcatheter aortic valve replacement: a systematic review."
Heart, Lung and Circulation 25.10 (2016): 968-974. cited by
applicant .
Urena, Marina, et al. "Transseptal transcatheter mitral valve
replacement using balloon-expandable transcatheter heart valves: a
step-by-step approach." JACC: Cardiovascular Interventions 10.19
(2017): 1905-1919. cited by applicant .
An English summary of an Official Action dated Mar. 29, 2021, which
issued during the prosecution of Chinese Patent Application No.
201780061210.3. cited by applicant .
An International Search Report and a Written Opinion both dated
Jan. 28, 2020, which issued during the prosecution of Applicant's
PCT/IL2019/051031. cited by applicant .
An International Preliminary Report on Patentability dated Mar. 9,
2021, which issued during the prosecution of Applicant's
PCT/IL2019/051031. cited by applicant .
An Office Action dated May 4, 2021, which issued during the
prosecution of U.S. Appl. No. 16/636,204. cited by applicant .
Notice of Allowance dated May 17, 2021, which issued during the
prosecution of U.S. Appl. No. 16/138,129. cited by applicant .
Notice of Allowance dated Jun. 4, 2021, which issued during the
prosecution of U.S. Appl. No. 16/802,353. cited by applicant .
An Office Action dated May 12, 2021, which issued during the
prosecution of Canadian Patent Application No. 2,973,940. cited by
applicant .
Petition for Inter Partes Review of U.S. Pat. No. 10,702,385--dated
Jun. 4, 2021. cited by applicant .
Declaration of Ivan Vesely, Ph.D. In Support of Petition for Inter
Partes Review of U.S. Pat. No. 10,702,385--dated Jun. 4, 2021.
cited by applicant .
European Search Report dated Jun. 10, 2021 which issued during the
prosecution of Applicant's European App No. 21157988.3. cited by
applicant .
An Invitation to pay additional fees dated May 19, 2021, which
issued during the prosecution of Applicant's PCT/IL2021/050132.
cited by applicant .
An International Search Report and a Written Opinion both dated
Jul. 12, 2021, which issued during the prosecution of Applicant's
PCT/IL2021/050132. cited by applicant .
IPR2021-00383 Petitioners' Authorized Reply to Patent Owner's
Preliminary Response dated May 27, 2021. cited by applicant .
Exhibit 1014--Transcript of proceedings held May 20, 2021 (Edwards
Lifesciences vs. Cardiovalve). cited by applicant .
Exhibit 1015--Facilitate, Meriam-Webster.com,
https://www.merriamwebster.com/dictionary/facilitate (visited May
26, 2021). cited by applicant .
Patent Owner's Authorized Surreply to Petitioner's Reply to Patent
Owner's Preliminary Response dated Jun. 4, 2021 (Edwards
Lifesciences vs. Cardiovalve). cited by applicant .
An Office Action dated Aug. 18, 2021, which issued during the
prosecution of U.S. Appl. No. 17/210,183. cited by applicant .
Institution decision dated Jul. 20, 2021(Edwards Lifesciences vs.
Cardiovalve). cited by applicant .
An Office Action dated Dec. 24, 2020, which issued during the
prosecution of U.S. Appl. No. 16/144,054. cited by applicant .
An Office Action dated Feb. 2, 2021, which issued during the
prosecution of U.S. Appl. No. 16/811,732. cited by applicant .
An Office Action dated Jan. 13, 2021, which issued during the
prosecution of European Patent Application No. 15751089.2. cited by
applicant .
Maisano, F., et al. "The edge-to-edge technique: a simplified
method to correct mitral insufficiency." European journal of
cardio-thoracic surgery 13.3 (1998): 240-246. cited by applicant
.
Declaration of Dr. Ivan Vesely, Ph.D. in Support of Petition for
Inter Partes Review of U.S. Pat. No. 10,226,341--dated Dec. 17,
2020. cited by applicant .
Petition for Inter Partes Review of U.S. Pat. No. 10,226,341 and
Exhibits 1001-1013--dated Dec. 29, 2020. cited by applicant .
An Office Action together with an English summary dated Mar. 3,
2021, which issued during the prosecution of Chinese Patent
Application No. 201780047391.4. cited by applicant .
Fucci, C., et al. "Improved results with mitral valve repair using
new surgical techniques." European journal of cardio-thoracic
surgery 9.11 (1995): 621-627. cited by applicant .
Declaration of Ivan Vesely, Ph.D., in Support of Petition for Inter
PartesReview of U.S. Pat. No. 7,563,267--dated May 29, 2019. cited
by applicant .
U.S. Appl. No. 60/128,690, filed Apr. 9, 1999. cited by applicant
.
Batista, Randas JV, et al. "Partial left ventriculectomy to treat
end-stage heart disease." The Annals of thoracic surgery 64.3
(1997): 634-638. cited by applicant .
Beall Jr, Arthur C., et al. "Clinical experience with a dacron
velour-covered teflon-disc mitral-valve prosthesis." The Annals of
thoracic surgery 5.5 (1968): 402-410. cited by applicant .
Kalbacher, D., et al. "1000 MitraClip.TM. procedures: Lessons
learnt from the largest single-centre experience worldwide."
(2019): 3137-3139. cited by applicant .
U.S. Appl. No. 60/613,867, filed Sep. 27, 2004. cited by applicant
.
Mitral Valve Academic Research Consortium. "Clinical Trial Design
Principles and Endpoint Definitions for Transcatheter Mitral Valve
Repair and Replacement: Part 1: Clinical Trial Design Principles a
Consensus Document from the Mitral Valve Academic Research
Consortium." Journal of the American College of Cardiology 66.3
(2015): 278-307. cited by applicant .
Office Action dated Apr. 11, 2022 in U.S. Appl. No. 17/473,472.
cited by applicant .
Office Action dated Jan. 26, 2022 in U.S. Appl. No. 16/888,210.
cited by applicant .
Notice of Allowance dated Jan. 31, 2022 in U.S. Appl. No.
17/479,418. cited by applicant .
Preliminary Guidance Patent Owner's Motion to Amend dated Jan. 31,
2022 in IPR2021-00383. cited by applicant .
Office Action dated Mar. 18, 2022 in U.S. Appl. No. 16/746,489.
cited by applicant .
Notice of Allowance dated Mar. 4, 2022 in U.S. Appl. No.
16/768,909. cited by applicant .
Notice of Allowance dated Mar. 22, 2022 in U.S. Appl. No.
17/366,711. cited by applicant .
Office Action dated Jan. 24, 2022 in U.S. Appl. No. 16/135,466.
cited by applicant .
Office Action dated Dec. 9, 2021 in U.S. Appl. No. 16/135,969.
cited by applicant .
An Office Action dated Nov. 25, 2021, which issued during the
prosecution of European Patent Application No. 18826823.9. cited by
applicant .
IPR2021-01051 Institution decision dated Dec. 10, 2021. cited by
applicant .
Notice of Allowance dated Dec. 7, 2021, which issued during the
prosecution of U.S. Appl. No. 17/394,807. cited by applicant .
Notice of Allowance dated Dec. 6, 2021, which issued during the
prosecution U.S. Appl. No. 16/738,516. cited by applicant .
Notice of Allowance dated Dec. 29, 2021, which issued during the
prosecution of U.S. Appl. No. 17/210,183. cited by applicant .
IPR2021-00383 Petitioners' Reply to Patent Owner's Response dated
Jan. 5, 2022. cited by applicant .
IPR2021-00383 Petitioners' Opposition to Patent Owner's Contingent
Motion to Amend dated Jan. 5, 2022. cited by applicant .
An Office Action dated Sep. 22, 2021, which issued during the
prosecution of European Patent Application No. 20714289.4. cited by
applicant .
Summary of Examination Notice dated Jan. 6, 2022, which issued
during the prosecution of Chinese Patent Application No.
201880064313.X. cited by applicant .
An Office Action dated Jan. 12, 2022, which issued during the
prosecution of U.S. Appl. No. 17/101,787. cited by applicant .
An Office Action dated Sep. 9, 2021, which issued during the
prosecution of U.S. Appl. No. 16/768,909. cited by applicant .
An Office Action dated Sep. 15, 2021, which issued during the
prosecution of U.S. Appl. No. 16/135,599. cited by applicant .
IPR2021-00383 Deposition of Dr. Ivan Vesely, dated Sep. 22, 2021.
cited by applicant .
An Office Action dated Oct. 21, 2021, which issued during the
prosecution of U.S. Appl. No. 17/335,845. cited by applicant .
European Search Report dated Oct. 11, 2021 which issued during the
prosecution of Applicant's European App No. 21176010.3. cited by
applicant .
Fann, James I., et al. "Beating heart catheter-based edge-to-edge
mitral valve procedure in a porcine model: efficacy and healing
response." Circulation 110.8 (2004): 988-993. cited by applicant
.
Feldman, Ted, et al. "Percutaneous mitral repair with the MitraClip
system: safety and midterm durability in the initial Everest
(Endovascular Valve Edge-to-Edge REpair Study) cohort." Journal of
the American College of Cardiology 54.8 (2009): 686-694. cited by
applicant .
IPR2021-00383 Patent Owner's Contingent Motion to Amend Under 37
C.F.R. .sctn.42.121 dated Oct. 13, 2021. cited by applicant .
IPR2021-00383 Patent Owner's Response Pursuant to 37 C.F.R. .sctn.
42.120 dated Oct. 13, 2021. cited by applicant .
IPR2021-00383 Second Declaration of Dr. Michael Sacks dated Oct.
13, 2021. cited by applicant .
An Office Action dated Oct. 21, 2021, which issued during the
prosecution of U.S. Appl. No. 17/306,231. cited by applicant .
Maisano, Francesco, et al. "The evolution from surgery to
percutaneous mitral valve interventions: the role of the
edge-to-edge technique." Journal of the American College of
Cardiology 58.21 (2011): 2174-2182. cited by applicant .
Cardiovalve Exhibit 2009--Percutaneous Mitral Leaflet Repair:
MitraClip.RTM. Therapy for Mitral Regurgitation (2012). cited by
applicant .
Feldman, Ted, et al. "Percutaneous mitral valve repair using the
edge-to-edge technique: six-month results of the Everest Phase I
Clinical Trial." Journal of the American College of Cardiology
46.11 (2005): 2134-2140. cited by applicant .
An Office Action summarized English translation and Search Report
dated Oct. 8, 2021, which issued during the prosecution of Chinese
Patent Application No. 201780061210.3. cited by applicant .
An Office Action dated Nov. 4, 2021, which issued during the
prosecution of U.S. Appl. No. 17/366,711. cited by applicant .
An Office Action summarized English translation and Search Report
dated Aug. 12, 2021, which issued during the prosecution of Chinese
Patent Application No. 201880058940.2. cited by applicant.
|
Primary Examiner: Lynch; Robert A
Attorney, Agent or Firm: Sughrue Mion, PLLC
Parent Case Text
CROSS-REFERENCES TO RELATED APPLICATIONS
The present application is a Continuation of U.S. Ser. No.
15/691,032 to HaCohen et al., filed Aug. 30, 2017 (now U.S. Pat.
No. 10,512,456),
which is a Continuation of U.S. patent application Ser. No.
14/689,608 to HaCohen et al., filed Apr. 17, 2015 (now U.S. Pat.
No. 9,763,657),
which is a Continuation of U.S. patent application Ser. No.
13/811,308 to Gross et al. (now U.S. Pat. No. 9,017,399),
which is the US National Phase of PCT application IL2011/000582 to
Gross et al., filed Jul. 21, 2011, which published as WO
2012/011108, and
which: (1) claims priority and is a continuation-in-part of: (a)
U.S. Ser. No. 12/840,463 to Hacohen et al., filed Jul. 21, 2010,
entitled "Guide wires with commissural anchors to advance a
prosthetic valve" (now U.S. Pat. No. 9,132,009), and (b) U.S. Ser.
No. 13/033,852 to Gross et al., filed Feb. 24, 2011, entitled
"Techniques for percutaneous mitral valve replacement and sealing"
(now U.S. Pat. No. 8,992,604), which is a continuation-in-part of
U.S. Ser. No. 12/840,463, and (2) claims priority from U.S.
Provisional Patent Application 61/492,449 to Gross et al., filed
Jun. 2, 2011, and entitled "Techniques for percutaneous mitral
valve replacement and sealing."
Claims
The invention claimed is:
1. A method, for use at a mitral valve of a heart of a subject, the
method comprising: advancing a transluminal sheath into a femoral
vein of the subject, through an inferior vena cava of the subject,
into a right atrium of the subject, and transseptally into a left
atrium of the subject; advancing a distal end of a
surrounding-sheath out of a distal end of the transluminal sheath,
into the left atrium, and toward a commissure of the mitral valve;
at the commissure, advancing a distal end of a delivery lumen and
an anchor out of the distal end of the surrounding-sheath, into a
left ventricle of the subject, and, while the distal end of the
delivery lumen is in the left ventricle, helically implanting the
anchor by wrapping the anchor around at least some chordae
tendineae that are at the commissure; subsequently to helically
implanting the anchor, extracting the surrounding-sheath and the
delivery lumen from the heart; and subsequently, implanting a
prosthetic valve in the mitral valve such that the anchor
facilitates anchoring of the prosthetic valve and sealing of the
commissure.
2. The method according to claim 1, wherein the anchor is a first
anchor and the commissure is a first commissure of the mitral
valve, wherein the method further comprises, subsequently to
helically implanting the first anchor at the first commissure,
helically implanting a second anchor by wrapping the second anchor
around at least some chordae tendineae that are at a second
commissure of the mitral valve, and wherein implanting the
prosthetic valve in the mitral valve comprises implanting the
prosthetic valve in the mitral valve such that the first and second
anchors facilitate anchoring of the prosthetic valve and sealing of
the first and second commissures.
3. The method according to claim 2, wherein: the surrounding-sheath
is a first surrounding-sheath, the delivery lumen is a first
delivery lumen, the method further comprises advancing a distal end
of a second surrounding-sheath out of the distal end of the
transluminal sheath, into the left atrium, and toward the second
commissure, and helically implanting the second anchor comprises,
at the second commissure, advancing a distal end of a second
delivery lumen out of the distal end of the second
surrounding-sheath, into the left ventricle.
4. The method according to claim 1, wherein the is conical, having
a wider end and a narrower end, and wherein helically implanting
the anchor comprises helically implanting the anchor that is
conical, having a wider end and a narrower end.
5. The method according to claim 4, wherein helically implanting
the anchor comprises helically implanting the anchor such that the
wider end is upstream of the narrower end.
6. The method according to claim 1, further comprising, prior to
the advancing of the distal end of the surrounding-sheath,
advancing a guide member to the commissure, and wherein advancing
the distal end of the surrounding-sheath comprises sliding the
distal end of the surrounding-sheath around the guide member.
7. The method according to claim 1, wherein helically implanting
the anchor comprises positioning the anchor such that a wider end
of the anchor is upstream of a narrower end of the anchor.
8. The method according to claim 1, wherein helically implanting
the anchor comprises positioning the anchor such that a curved
portion of the anchor having a greater radius of curvature is
upstream of a curved portion of the anchor having a smaller radius
of curvature.
9. The method according to claim 1, further comprising,
subsequently to the extracting of the surrounding-sheath, advancing
a guide wire through the transluminal sheath.
10. The method according to claim 9, further comprising,
subsequently to the advancing of the guide wire, advancing the
prosthetic valve along the guide wire.
Description
FIELD OF THE INVENTION
Embodiments of the present invention relate in general to valve
replacement. More specifically, embodiments of the present
invention relate to prosthetic valves for replacement of an
atrioventricular valve.
BACKGROUND
Dilation of the annulus of the mitral valve prevents the valve
leaflets from fully coapting when the valve is closed.
Regurgitation of blood from the ventricle into the atrium results
in increased total stroke volume and decreased cardiac output, and
ultimate weakening of the ventricle secondary to a volume overload
and a pressure overload of the atrium. Dilation of the annulus is
sometimes treated by implanting a prosthetic mitral valve at a
patient's native mitral valve.
SUMMARY
For some applications of the present invention, one or more guide
members (e.g., wires, sutures, or strings) is configured to be
anchored to respective commissures of a native atrioventricular
valve of a patient, and each guide member facilitates the
advancement therealong of respective commissural anchors. The
commissural anchors are shaped so as to define a plurality of barbs
or prongs which are expandable to restrict proximal movement of the
anchors following their deployment. The guide members facilitate
advancement of a collapsible prosthetic valve support (e.g., a
skirt) which serves as a base for and receives a collapsible
prosthetic mitral valve which is subsequently coupled to the
support. The support comprises a proximal annular element, or ring,
and a distal cylindrical element. The cylindrical element is
configured to push aside and press against the native leaflets of
the native valve, and the proximal annular element is shaped so as
to define one or more holes for sliding the valve support along the
one or more guide members. The proximal annular element is
configured to be positioned along the annulus of the native
valve.
The collapsible prosthetic valve is configured for implantation in
and/or at least partial replacement (e.g., full replacement) of the
native atrioventricular valve of the patient, such as a native
mitral valve or a native tricuspid valve. The valve support and the
prosthetic valve are configured to assume collapsed states for
minimally-invasive delivery to the diseased native valve, such as
by percutaneous or transluminal delivery using one or more
catheters. For some applications, the valve support and the
prosthetic valve are implanted during an open-heart procedure.
The prosthetic valve support is shaped so as to define a downstream
skirt. The downstream skirt is configured to be placed at native
valve, such that the downstream skirt passes through the orifice of
the native valve and extends toward, and, typically partially into,
a ventricle. The downstream skirt typically additionally pushes
aside and presses against the native leaflets of the native valve,
which are left in place during and after implantation of the
prosthetic valve support and/or the prosthetic valve.
The proximal annular element has upper and lower surfaces. For some
applications of the present invention, one or more, e.g., a
plurality of, tissue anchors are coupled to the lower surface and
facilitate anchoring of the proximal annular element to the annulus
of the native valve. For some applications, the one or more anchors
comprise at least first and second commissural anchors that are
configured to be implanted at or in the vicinity of the commissures
of the native valve.
The cylindrical element of the valve support has first and second
ends and a cylindrical body disposed between the first and second
ends. The first end of the cylindrical element is coupled to the
annular element while the second end defines a free end of the
cylindrical element. For some applications of the present
invention, the cylindrical element of the valve support is
invertible such that (1) during a first period, the second end and
the cylindrical body of the cylindrical element are disposed above
the annular element (e.g., in the atrium of the heart), and (2)
during a second period, the second end and the cylindrical body of
the cylindrical element are disposed below the annular element
(e.g., in the ventricle of the heart).
For some applications, techniques are applied to facilitate sealing
of the interface between the valve support and the native valve,
and/or the interface between the prosthetic valve and the native
valve. For example, a sealing balloon may be placed on a
valve-facing, lower side of the annular element of the valve
support, the sealing balloon being configured to be inflated such
that the balloon seals the interface between the valve support and
the native valve. Alternatively or additionally, commissural
helices are wrapped around chordae tendineae of the patient in
order to facilitate sealing of the valve commissures around the
valve support and/or around the valve. Further alternatively or
additionally, the valve commissures are grasped by grasping
elements that act in order to facilitate sealing of the commissures
around the valve support and/or around the valve. For some
applications, one or more of the aforementioned sealing elements
facilitates anchoring of the prosthetic valve to the native valve
in addition to facilitating sealing.
For some applications, the prosthetic valve comprises an expandable
frame (e.g., a wire frame), and a sealing material (such as latex)
is disposed on the outer surface of the frame so as to form webbing
between at least some of the struts of the wire frame, and to
provide sealing between the wire frame and the native valve.
For some applications, an invertible prosthetic valve support is
used to support a prosthetic valve. Typically, a sealing element is
disposed circumferentially around a surface of the invertible
prosthetic valve support that is initially an inner surface of the
invertible prosthetic valve support. The invertible prosthetic
valve support is anchored to the native valve, and is subsequently
inverted. Subsequent to the inversion of the invertible prosthetic
valve support, the sealing element is disposed on the outer surface
of the invertible prosthetic valve support and acts to seal the
interface between the outer surface and the native valve.
There is therefore provided, in accordance with some applications
of the present invention, apparatus, including:
a prosthetic valve support configured to be placed at an annulus of
a native atrioventricular valve of a patient, the prosthetic valve
support defining an annular element that defines an inner
cross-sectional area thereof;
an expandable prosthetic valve configured to be placed into a
ventricle of the patient, the prosthetic valve including: an
expandable frame; and prosthetic valve leaflets coupled to the
expandable frame;
the expandable frame of the prosthetic valve being configured such
that when the frame is in a non-constrained state thereof, a
cross-sectional area of the frame, along at least a given portion
of a length of the frame, is greater than the cross-sectional area
defined by the annular element of the prosthetic valve support,
the prosthetic valve thereby being couplable to the prosthetic
valve support at any location along the portion, responsively to
radial forces acted upon the valve support by the expandable frame,
by the expandable frame being expanded when the location along the
portion is aligned with the annular element of the prosthetic valve
support.
For some applications, the valve support is collapsible for
transcatheter delivery.
For some applications, the native atrioventricular valve includes a
mitral valve, and the prosthetic valve includes three prosthetic
leaflets.
For some applications, the annular element of the valve support is
asymmetrically shaped.
For some applications, the annular element is shaped to define a
hole, and a center of the hole is disposed asymmetrically with
respect to an outer perimeter of the annular element.
For some applications, the frame includes proximally-facing
protrusions at a distal end thereof, the protrusions being
configured to prevent proximal migration of the valve into an
atrium.
For some applications, the protrusions are disposed at an angle
from the frame of more than 40 degrees.
For some applications, the protrusions are disposed at an angle
from the frame of less than 80 degrees.
For some applications, a length of each of the protrusions is less
than 5 mm.
For some applications, the frame includes a single
proximally-facing protrusion corresponding to each native valve
leaflet of the valve, each of the protrusions having a width of
less than 1 mm.
For some applications, the protrusions are disposed in a sinusoidal
configuration such that the protrusions conform with a saddle shape
of the patient's native annulus.
For some applications, the protrusions are configured to prevent
the native leaflets from interfering with a left ventricular
outflow tract of the patient.
For some applications, the frame includes first and second sets of
one or more protrusions, each set of protrusions configured to
ensnare a respective native leaflet of the native valve of the
patient, the first set of protrusions being disposed within a first
circumferential arc with respect to a longitudinal axis of the
prosthetic valve, on a first side of a distal end of the frame, the
second set of protrusions being disposed within a second
circumferential arc with respect to the longitudinal axis of the
prosthetic valve, on a second side of the distal end of the frame,
the first and second sets being disposed so as to provide first and
second gaps therebetween at the distal end of the frame, at least
one of the gaps having a circumferential arc of at least 20
degrees, the apparatus further including one or more valve guide
members configured to be delivered to one or more commissures of
the native valve, and to guide the valve such that the first and
second circumferential arcs are aligned with respective leaflets of
the native valve and such that the first and second gaps are
aligned with respective commissures of the native valve.
For some applications, the at least one of the gaps has a
circumferential arc of at least 60 degrees.
For some applications, the first circumferential arc defines an
angle of between 25 degrees and 90 degrees about the longitudinal
axis of the prosthetic valve.
For some applications, the second circumferential arc defines an
angle of between 25 degrees and 90 degrees about the longitudinal
axis of the prosthetic valve.
For some applications, the first circumferential arc defines an
angle of between 45 degrees and 75 degrees about the longitudinal
axis of the prosthetic valve.
For some applications, the second circumferential arc defines an
angle of between 45 degrees and 75 degrees about the longitudinal
axis of the prosthetic valve.
For some applications, the expandable frame of the prosthetic valve
is configured such that when the frame is in a non-constrained
state thereof the frame has a maximum diameter of less than 25
mm.
For some applications, the expandable frame of the prosthetic valve
is configured such that when the frame is in a non-constrained
state thereof the frame has a maximum diameter of more than 15
mm.
For some applications, the expandable frame of the prosthetic valve
is configured such that when the frame is in a non-constrained
state thereof the frame has a maximum diameter of less than 20
mm.
For some applications, the expandable frame of the prosthetic valve
is configured such that when the frame is in a non-constrained
state thereof, a cross-sectional area of the frame at a proximal
end of the frame is greater than a cross-sectional area of the
frame at a distal end of the frame.
For some applications, the expandable frame of the prosthetic valve
is configured such that when the frame is in the non-constrained
state thereof the frame defines a frustoconical shape.
For some applications, the expandable frame of the prosthetic valve
is configured such that when the frame is in the non-constrained
state thereof the frame defines a trumpet shape.
There is further provided, in accordance with some applications of
the present invention, a method, including:
placing a prosthetic valve support at an annulus of a native
atrioventricular valve of a patient, the prosthetic valve support
defining an annular element that defines an inner cross-sectional
area thereof;
placing into a ventricle of the patient, an expandable prosthetic
valve, the prosthetic valve including an expandable frame, and
prosthetic valve leaflets coupled to the expandable frame, the
expandable frame of the prosthetic valve being configured such that
when the frame is in a non-constrained state thereof, a
cross-sectional area of the frame, along at least a given portion
of a length of the frame, is greater than the cross-sectional area
defined by the annular element of the prosthetic valve support;
determining a location anywhere along the portion at which to
couple the expandable valve the prosthetic valve support; and
in response thereto,
aligning the location along the portion of the expandable frame
with the annular element of the prosthetic valve support; and
coupling the expandable valve to the prosthetic valve support at
the location, responsively to radial forces acted upon the valve
support by the expandable frame, by facilitating expansion of the
expandable frame, when the location along the portion is aligned
with the annular element of the prosthetic valve support.
For some applications, placing the valve support at the annulus
includes transcatheterally placing the valve support at the annulus
in a collapsed state.
For some applications, the native atrioventricular valve includes a
mitral valve, and placing the prosthetic valve into the ventricle
includes placing into the ventricle a prosthetic valve that
includes three prosthetic leaflets.
For some applications, placing the prosthetic valve support at the
annulus includes placing an asymmetrically-shaped prosthetic valve
support at the annulus.
For some applications, placing the prosthetic valve support at the
annulus includes placing at the annulus an annular element that is
shaped to define a hole, a center of the hole being disposed
asymmetrically with respect to an outer perimeter of the annular
element, the annular element being placed such that a center of the
hole is disposed asymmetrically with respect to the annulus.
For some applications, the frame includes proximally-facing
protrusions at a distal end thereof, the protrusions being
configured to prevent proximal migration of the valve into an
atrium, and coupling the expandable valve to the prosthetic valve
support includes preventing proximal migration of the valve by
coupling the valve to the valve support such that the leaflets are
disposed at least partially between the protrusions and the valve
support.
For some applications, coupling the expandable valve to the
prosthetic valve support includes preventing the native leaflets
from interfering with a left ventricular outflow tract of the
patient.
For some applications, coupling the expandable valve to the
prosthetic valve support includes allowing movement of the leaflets
with respect to the frame while preventing the proximal migration
of the valve.
For some applications, the frame includes first and second sets of
one or more protrusions, each set of protrusions configured to
ensnare a respective native leaflet of the native valve of the
patient, the first set of protrusions being disposed within a first
circumferential arc with respect to a longitudinal axis of the
prosthetic valve, on a first side of a distal end of the frame, the
second set of protrusions being disposed within a second
circumferential arc with respect to the longitudinal axis of the
prosthetic valve, on a second side of the distal end of the frame,
the first and second sets being disposed so as to provide first and
second gaps therebetween at the distal end of the frame, at least
one of the gaps having a circumferential arc of at least 20
degrees, the method further including guiding the valve such that
the first and second circumferential arcs are aligned with
respective leaflets of the native valve and such that the first and
second gaps are aligned with respective commissures of the native
valve.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame to a maximum diameter of less
than 25 mm.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame to a maximum diameter of more
than 15 mm.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame to a maximum diameter of less
than 20 mm.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame such that a cross-sectional
area of the frame at a proximal end of the frame is greater than a
cross-sectional area of the frame at a distal end of the frame.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame such that the frame defines a
frustoconical shape.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame such that the frame defines a
trumpet shape.
There is additionally provided, in accordance with some
applications of the present invention, a method, including:
determining an indication of an area defined by an annulus of a
native atrioventricular valve of a patient;
selecting a prosthetic valve support by determining that the
prosthetic valve support defines an annular element that defines an
inner cross-sectional area that is less than the area defined by
the annulus;
placing the prosthetic valve support at the annulus of the native
atrioventricular valve;
placing into a ventricle of the patient, an expandable prosthetic
valve, the prosthetic valve including an expandable frame, and
prosthetic valve leaflets coupled to the expandable frame;
coupling the expandable valve to the prosthetic valve support at
the location, responsively to radial forces acted upon the valve
support by the expandable frame, by facilitating expansion of the
expandable frame,
a cross-sectional area defined by the expandable frame of the
prosthetic valve being limited by the cross-sectional area defined
by the annular element of the prosthetic valve support, such as to
facilitate sealing of the native valve with respect to the
prosthetic valve by facilitating closing of leaflets of the native
valve around the prosthetic valve, upon deployment of the
prosthetic valve.
For some applications, facilitating closing of leaflets of the
native valve around the prosthetic valve includes facilitating
sealing of the native valve at commissures of the native valve.
For some applications, facilitating closing of leaflets of the
native valve around the prosthetic valve includes facilitating
closing of the leaflets of the native valve around an outer surface
of the expandable frame.
For some applications, placing the valve support at the annulus
includes transcatheterally placing the valve support at the annulus
in a collapsed state.
For some applications, the native atrioventricular valve includes a
mitral valve, and placing the prosthetic valve into the ventricle
includes placing into the ventricle a prosthetic valve that
includes three prosthetic leaflets.
For some applications, placing the prosthetic valve support at the
annulus includes placing an asymmetrically-shaped prosthetic valve
support at the annulus.
For some applications, placing the prosthetic valve support at the
annulus includes placing at the annulus an annular element that is
shaped to define a hole, a center of the hole being disposed
asymmetrically with respect to an outer perimeter of the annular
element, the annular element being placed such that a center of the
hole is disposed asymmetrically with respect to the annulus.
For some applications, the frame includes proximally-facing
protrusions at a distal end thereof, the protrusions being
configured to prevent proximal migration of the valve into an
atrium, and coupling the expandable valve to the prosthetic valve
support includes preventing proximal migration of the valve by
coupling the valve to the valve support such that the leaflets are
disposed at least partially between the protrusions and the valve
support.
For some applications, coupling the expandable valve to the
prosthetic valve support includes preventing the native leaflets
from interfering with a left ventricular outflow tract of the
patient.
For some applications, coupling the expandable valve to the
prosthetic valve support includes allowing movement of the leaflets
with respect to the frame while preventing proximal migration of
the valve.
For some applications, the frame includes first and second sets of
one or more protrusions, each set of protrusions configured to
ensnare a respective native leaflet of the native valve of the
patient, the first set of protrusions being disposed within a first
circumferential arc with respect to a longitudinal axis of the
prosthetic valve, on a first side of a distal end of the frame, the
second set of protrusions being disposed within a second
circumferential arc with respect to the longitudinal axis of the
prosthetic valve, on a second side of the distal end of the frame,
the first and second sets being disposed so as to provide first and
second gaps therebetween at the distal end of the frame, at least
one of the gaps having a circumferential arc of at least 20
degrees, the method further including guiding the valve such that
the first and second circumferential arcs are aligned with
respective leaflets of the native valve and such that the first and
second gaps are aligned with respective commissures of the native
valve.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame to a maximum diameter of less
than 25 mm.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame to a maximum diameter of more
than 15 mm.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame to a maximum diameter of less
than 20 mm.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame such that a cross-sectional
area of the frame at a proximal end of the frame is greater than a
cross-sectional area of the frame at a distal end of the frame.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame such that the frame defines a
frustoconical shape.
For some applications, facilitating expansion of the frame includes
facilitating expansion of the frame such that the frame defines a
trumpet shape.
There is additionally provided, in accordance with some
applications of the present invention, a method, including:
placing a prosthetic valve support at an annulus of a native
atrioventricular valve of a patient;
placing a prosthetic valve into a ventricle of the patient, the
prosthetic valve including protrusions at a distal end thereof;
ensnaring one or more native leaflets of the native valve of the
patient with the protrusions; and
coupling the prosthetic valve to the native valve, by sandwiching
native leaflets of the native valve between the protrusions and the
valve support, by pulling the prosthetic valve proximally with
respect to the valve support, and while the native leaflets are
sandwiched between the protrusions and the valve support, coupling
the prosthetic valve to the valve support, by facilitating radial
expansion of the prosthetic valve such that the prosthetic valve is
held in place with respect to the valve support responsively to
radial forces acted upon the valve support by the prosthetic
valve.
There is further provided, in accordance with some applications of
the present invention, a method, including:
determining an indication of an area defined by an annulus of a
native atrioventricular valve of a patient;
selecting a prosthetic valve to be placed in the native valve by
determining that the valve defines a cross-sectional area that is
less than 90% of the area defined by the annulus; and
deploying the prosthetic valve at the native valve,
the selecting of the prosthetic valve facilitating sealing of the
native valve with respect to the prosthetic valve by facilitating
closing of leaflets of the native valve around the prosthetic
valve, upon deployment of the prosthetic valve.
For some applications, selecting the prosthetic valve includes
selecting a prosthetic valve having a material disposed on an outer
surface thereof.
For some applications, selecting the prosthetic valve includes
selecting a prosthetic valve having a material that prevents tissue
growth disposed on an outer surface thereof.
For some applications, selecting the prosthetic valve includes
selecting a prosthetic valve having a material that promotes tissue
growth disposed on an outer surface thereof.
For some applications, selecting the prosthetic valve to be placed
in the native valve includes determining that the valve defines a
cross-sectional area that is less than 80% of the area defined by
the annulus.
For some applications, selecting the prosthetic valve to be placed
in the native valve includes determining that the valve defines a
cross-sectional area that is less than 60% of the area defined by
the annulus.
There is further provided, in accordance with some applications of
the present invention, apparatus, including:
one or more valve support guide members configured to be delivered
to one or more commissures of a native atrioventricular valve of a
patient;
one or more valve support anchors configured to be anchored to the
one or more commissures of the native valve;
a prosthetic valve support advanceable toward the native valve
along the one or more valve support guide members and anchored to
the native valve at at least the one or more commissures; and
a prosthetic valve configured to be coupled to the valve
support.
For some applications, the valve support is collapsible for
transcatheter delivery and expandable to contact the native
atrioventricular valve.
For some applications, the one or more valve support anchors are
configured to be anchored to the one or more commissures from
ventricular surfaces thereof.
For some applications, the one or more valve support guide members
includes one valve support guide member that is looped through
first and second commissures of the atrioventricular valve in a
manner in which a looped portion of the valve support guide member
is disposed in a ventricle of the patient and first and second free
ends of the valve support guide member are accessible from a site
outside a body of the patient.
For some applications, the one or more valve support anchors
includes first and second tissue anchors, the first and second
tissue anchors being configured to be anchored to respective first
and second commissures of the atrioventricular valve of the
patient.
For some applications:
the one or more valve support anchors each include one or more
radially-expandable prongs, and
the one or more prongs are disposed within a sheath in a compressed
state prior to the anchoring, and exposed from within the sheath in
order to expand and facilitate anchoring of the valve support
anchor to the respective commissures.
For some applications, the prosthetic valve includes two or more
prosthetic leaflets.
For some applications, the native atrioventricular valve includes a
mitral valve, and the prosthetic valve includes three prosthetic
leaflets.
For some applications, the valve support guide members are
removable from the patient following the anchoring of the
prosthetic valve support at the atrioventricular valve.
For some applications, the valve support is shaped so as to define
a distal portion which is configured to push aside, at least in
part, native leaflets of the valve of the patient.
For some applications, the one or more valve support anchors are
advanceable along the one or more valve support guide members.
For some applications, the valve support is shaped so as to define
one or more holes, the one or more holes being configured to
facilitate slidable passage therethrough of a respective one of the
one or more valve support guide members.
For some applications, the prosthetic valve is shaped so as to
define one or more snares configured to ensnare one or more native
leaflets of the native valve of the patient.
For some applications, the one or more valve support anchors
includes one or more ventricular anchors, and the apparatus further
includes one or more atrial anchors, each atrial anchor being
configured to be advanced toward an atrial surface of the valve
support and anchor in place the valve support in a vicinity of a
respective one of the ventricular anchors.
For some applications, the apparatus includes one or more delivery
lumens, and:
each one of the one or more valve support anchors is removably
coupled to a distal end of a respective delivery lumen,
the delivery lumen is configured to facilitate advancement of the
one or more anchors along the one or more guide members, and
the delivery lumen is decoupled from the anchor following the
anchoring of the anchor to the one or more commissures.
For some applications, the one or more valve support guide members
are removable from the body of the patient following the
advancement of the one or more anchors along the one or more guide
members.
For some applications:
the valve support is shaped so as to define one or more holes,
the one or more holes are configured to facilitate slidable passage
therethrough of a respective one of the one or more delivery
lumens, and
the one or more delivery lumens are decoupleable from the
respective valve support anchor following the anchoring of the
valve support to at least the one or more commissures.
For some applications, the one or more delivery lumens are
removable from the body of the patient following the anchoring of
the valve support to at least the one or more commissures.
For some applications, the valve support includes an annular
element and a generally cylindrical element coupled to the annular
element, the generally cylindrical element being configured to push
aside native leaflets of the native valve, the cylindrical element
has first and second ends and a cylindrical body that is disposed
between the first and second ends.
For some applications, the apparatus includes one or more annular
element tissue anchors, the annular element has an upper surface
and a lower surface, and the lower surface is coupled to the one or
more annular element tissue anchors, the one or more annular
element tissue anchors being configured to puncture tissue of a
native annulus of the native valve of the patient.
For some applications, one or more annular element tissue anchors
includes a plurality of annular element tissue anchors positioned
around the lower surface of the annular element.
For some applications, the one or more annular element tissue
anchors includes a first commissural anchor configured to puncture
tissue of the native valve at a first commissure thereof, and a
second commissural anchor configured to puncture tissue of the
native valve at a second commissure thereof.
For some applications, each anchor of the one or more annular
element tissue anchors includes a distal pointed tip and one or
more radially-expandable prongs, the prongs being configured to
expand and facilitate anchoring of the anchor and restrict proximal
motion of the annular element tissue anchor.
For some applications, the apparatus includes one or more
prosthetic valve guide members reversibly couplable to the
cylindrical element in a vicinity of the second end of the
cylindrical element, the prosthetic valve guide members being
configured to facilitate advancement of the prosthetic valve
therealong and toward the valve support.
For some applications: the first end of the cylindrical element is
coupled to the annular element, during a first period, the second
end of the cylindrical element is disposed above the annular
element in a manner in which the body of the cylindrical element is
disposed above the annular element, and the cylindrical element is
invertible in a manner in which, during a second period, the second
end of the cylindrical element is disposed below the annular
element and the body of the cylindrical element is disposed below
the annular element.
For some applications:
during the first period, the second end of the cylindrical element
is disposed in an atrium of a heart of the patient and the annular
element is positioned along an annulus of the native valve,
the prosthetic valve is advanceable along the one or more
prosthetic valve guide members into a ventricle of the heart of the
patient, and
in response to advancement of the prosthetic valve into the
ventricle, the one or more prosthetic valve guide members are
pulled into the ventricle and pull the second end and the body of
the cylindrical element into the ventricle to invert the
cylindrical element.
There is further provided, in accordance with some applications of
the present invention, a method, including:
advancing one or more valve support guide members toward one or
more commissures of a native atrioventricular valve of a
patient;
advancing along the one or more valve support guide members one or
more valve support tissue anchors toward the one or more
commissures;
anchoring the one or more valve support tissue anchors to the one
or more commissures;
anchoring a prosthetic valve support at the native atrioventricular
valve by anchoring the prosthetic valve support at at least the one
or more commissures; and
coupling a prosthetic valve to the prosthetic valve support.
For some applications, the method includes removing the one or more
valve support guide members following the anchoring of the
prosthetic valve support at the native atrioventricular valve.
For some applications, advancing the one or more valve support
guide members toward the one or more commissures includes advancing
one guide member and looping the one guide member through first and
second commissures of the native atrioventricular valve in a manner
in which a looped portion of the guide member is disposed in a
ventricle of the patient and first and second free ends of the
guide member are accessible from a site outside a body of the
patient.
For some applications, anchoring the one or more valve support
anchors includes anchoring the one or more valve support anchors to
ventricular surface of the respective commissures of the native
valve.
For some applications, anchoring the one or more valve support
anchors includes anchoring first and second tissue anchors to
respective first and second commissures of the native valve.
For some applications:
advancing along the one or more valve support guide members the one
or more valve support tissue anchors includes advancing the one or
more valve support tissue anchors within a sheath, and
anchoring the one or more valve support tissue anchors includes
exposing the one or more valve support anchors from within the
sheath and facilitating radial expansion of one or more
radially-expandable prongs of the one or more anchors.
For some applications, coupling the prosthetic valve to the
prosthetic valve support includes coupling a prosthetic valve
having two or more leaflets.
For some applications, the native atrioventricular valve includes a
mitral valve of the patient, and coupling the prosthetic valve to
the prosthetic valve support includes coupling a prosthetic valve
having three leaflets.
For some applications, anchoring the prosthetic valve support
includes pushing aside, at least in part, native leaflets of the
valve of the patient by at least a portion of the support.
For some applications, the prosthetic valve support is coupled to
one or more annulus tissue anchors, and anchoring the prosthetic
valve support includes pushing the one or more annulus tissue
anchors into tissue of an annulus of the native valve.
For some applications, coupling the prosthetic valve to the
prosthetic valve support includes ensnaring one or more native
leaflets of the native valve of the patient by a portion of the
prosthetic valve.
For some applications, the one or more valve support anchors
includes one or more, ventricular anchors, and the method further
includes advancing one or more atrial anchors to an atrial surface
of the valve support, and anchoring in place the valve support in a
vicinity of a respective one of the ventricular anchors.
For some applications, the method includes advancing the valve
support along the one or more valve support guide members prior to
the anchoring of the valve support.
For some applications, the valve support is shaped so as to define
one or more holes, and advancing the valve support along the one or
more valve support guide members includes threading the one or more
valve support guide members through the one or more holes of the
valve support and sliding the valve support along the one or more
guide members.
For some applications, the method includes removing the one or more
valve support guide members from a body of the patient following
the anchoring of the valve support.
For some applications,
the valve support includes: an annular element, and a generally
cylindrical element having first and second ends and a cylindrical
body that is disposed between the first and second ends, the first
end being coupled to the annular element; and
anchoring of the valve support, including anchoring the valve
support in a manner in which: the annular element is positioned
along an annulus of the native valve, the second end of the
cylindrical element is disposed above the annular element in an
atrium of a heart of the patient, and the body of the cylindrical
element is disposed above the annular element.
For some applications, the method includes, following the
anchoring, inverting the cylindrical element to pull the second end
of the cylindrical element below the annular element and into a
ventricle of the heart, in a manner in which the body of the
cylindrical element is disposed below the annular element and
pushes aside one or more native leaflets of the valve of the
patient.
For some applications:
inverting the cylindrical element includes advancing the prosthetic
valve along one or more prosthetic valve guide members reversibly
coupled to the cylindrical element in a vicinity of the second end
thereof,
advancing the prosthetic valve includes advancing the prosthetic
valve into the ventricle to pull the prosthetic valve guide members
and the second end of the cylindrical element into the ventricle,
and
the method further includes following the advancing of the
prosthetic valve into the ventricle, pulling proximally the
prosthetic valve such that a proximal portion of the valve contacts
the valve support.
For some applications, pulling the prosthetic valve proximally
includes ensnaring the one or more leaflets of the valve by a
portion of the prosthetic valve.
For some applications, advancing the one or more valve support
anchors includes:
providing a respective delivery lumen coupled at a distal end
thereof to each one of the one or more anchors,
advancing each delivery lumen along a respective one of the one or
more valve support guide members,
facilitating anchoring of each one of the one or more anchors to
the one or more commissures by the respective delivery lumen,
and
decoupling the delivery lumen from each one of the one or more
valve support anchors following the anchoring of the one or more
valve support anchors.
For some applications, the method includes removing the one or more
valve support guide members from a body of the patient following
the anchoring of each one of the one or more valve support anchors
to the one or more commissures.
For some applications, the method includes advancing the prosthetic
valve support along the one or more delivery lumens prior to the
anchoring the support at the native atrioventricular valve.
For some applications, the valve support is shaped so as to define
one or more holes, and advancing the valve support along the one or
more delivery lumens includes threading the one or more delivery
lumens through the one or more holes of the valve support and
sliding the valve support along the one or more delivery
lumens.
For some applications, the method includes removing the one or more
delivery lumens from a body of the patient following the anchoring
the support at the atrioventricular valve.
There is additionally provided, in accordance with some
applications of the present invention, apparatus including a valve
support for receiving a prosthetic valve, the valve support
including:
an annular element configured to be positioned along a native
annulus of a native atrioventricular valve of a patient; and
a flexible generally cylindrical element configured to be
positioned in the native atrioventricular valve of the patient and
to push aside native leaflets of the native valve, the cylindrical
element having first and second ends and a cylindrical body that is
disposed between the first and second ends, and: the first end of
the cylindrical element is coupled to the annular element, during a
first period, the second end of the cylindrical element is disposed
above the annular element in a manner in which the body of the
cylindrical element is disposed above the annular element, and the
cylindrical element is invertible in a manner in which, during a
second period, the second end of the cylindrical element is
disposed below the annular element and the body of the cylindrical
element is disposed below the annular element.
For some applications, the cylindrical element includes a flexible
wireframe covered by a fabric.
For some applications, the valve support is collapsible for
transcatheter delivery and expandable to contact the native
atrioventricular valve.
For some applications, the annular element has an upper surface and
a lower surface, the lower surface is coupled to one or more
annular element tissue anchors configured to puncture tissue of the
native annulus of the patient.
For some applications, the one or more annular element tissue
anchors includes a plurality of annular element tissue anchors
positioned around the lower surface of the annular element.
For some applications, the one or more annular element tissue
anchors includes a first commissural annular element tissue anchor
configured to puncture tissue of the native valve at a first
commissure thereof, and a second commissural annular element tissue
anchor configured to puncture tissue of the native valve at a
second commissure thereof.
For some applications, each anchor of the one or more annular
element tissue anchors includes a distal pointed tip and one or
more radially-expandable prongs, the prongs being configured to
expand and facilitate anchoring of the anchor and restrict proximal
motion of the annular element tissue anchor.
For some applications, the apparatus includes one or more valve
support guide members configured to be delivered to one or more
commissures of the native atrioventricular valve of the patient,
the one or more valve support guide members are configured to
facilitate advancement of the valve support toward the native
valve.
For some applications, the valve support is shaped so as to define
one or more holes, the one or more holes configured to facilitate
slidable passage therethrough of a respective one of the one or
more valve support guide members.
For some applications, the one or more valve support guide members
includes one valve support guide member that is looped through
first and second commissures of the atrioventricular valve in a
manner in which a looped portion of the valve support guide member
is disposed in a ventricle of the patient and first and second free
ends of the valve support guide member are accessible from a site
outside a body of the patient.
For some applications, the apparatus includes one or more valve
support tissue anchors configured to be advanceable along the one
or more valve support guide members and anchored to the one or more
commissures of the valve.
For some applications, the one or more valve support anchors
includes one or more ventricular anchors, and the apparatus further
includes one or more atrial anchors, each atrial anchor being
configured to be advanced toward an atrial surface of the valve
support and anchor in place the valve support in a vicinity of a
respective one of the ventricular anchors.
For some applications, the valve support guide members are
removable from the patient following the anchoring of the valve
support at the atrioventricular valve.
For some applications, the one or more valve support anchors are
configured to be anchored to the one or more commissures from
ventricular surfaces thereof prior to advancement of the valve
support.
For some applications, the one or more valve support tissue anchors
includes first and second valve support tissue anchors, the first
and second valve support tissue anchors being configured to be
anchored to respective first and second commissures of the
atrioventricular valve of the patient.
For some applications:
the one or more valve support tissue anchors each include one or
more radially-expandable prongs, and
the one or more prongs are disposed within a sheath in a compressed
state prior to the anchoring and exposed from within the sheath in
order to expand and facilitate anchoring of the anchor to the
respective commissures.
For some applications, the apparatus includes one or more
prosthetic valve guide members reversibly couplable to the
cylindrical element in a vicinity of the second end of the
cylindrical element, the prosthetic valve guide members being
configured to facilitate advancement of the prosthetic valve
therealong and toward the valve support.
For some applications, the apparatus includes the prosthetic valve,
and the prosthetic valve is couplable to the valve support.
For some applications:
during the first period, the second end of the cylindrical element
is disposed in an atrium of a heart of the patient and the annular
element is positioned along an annulus of the native valve,
the prosthetic valve is advanceable along the one or more
prosthetic valve guide members into a ventricle of the heart of the
patient, and
in response to advancement of the prosthetic valve into the
ventricle, the one or more prosthetic valve guide members are
pulled into the ventricle and pull the second end of the
cylindrical element into the ventricle to invert the cylindrical
element.
For some applications, the prosthetic valve is collapsible for
transcatheter delivery and expandable when exposed from within a
delivery catheter.
For some applications, the prosthetic valve includes two or more
prosthetic leaflets.
For some applications, the native atrioventricular valve includes a
mitral valve, and the prosthetic valve includes three prosthetic
leaflets.
For some applications, the prosthetic valve guide members are
removable from the patient following the anchoring of the
prosthetic valve at the atrioventricular valve.
For some applications, the prosthetic valve is shaped so as to
define one or more snares configured to ensnare one or more native
leaflets of the native valve of the patient.
There is yet additionally provided, in accordance with some
applications of the present invention, a method, including:
advancing toward a native atrioventricular valve of a heart of a
patient, a valve support including: an annular element, and a
generally cylindrical element having first and second ends and a
cylindrical body that is disposed between the first and second
ends, the first end being coupled to the annular element;
anchoring the annular element to an annulus of the native
atrioventricular valve, following the anchoring, the second end of
the cylindrical element is disposed above the annular element in an
atrium of the heart, in a manner in which the body of the
cylindrical element is disposed above the annular element; and
following the anchoring, inverting the cylindrical element to pull
the second end of the cylindrical element below the annular element
and into a ventricle of the heart, in a manner in which the body of
the cylindrical element is disposed below the annular element and
pushes aside one or more native leaflets of the valve of the
patient.
For some applications, anchoring the annular element to the annulus
of the native atrioventricular valve includes:
advancing one or more valve support anchors that are distinct from
the valve support toward one or more commissures of the heart,
and
anchoring the annular element to the annulus using the one or more
positioning anchors.
For some applications, the annular element is coupled to one or
more annular element tissue anchors, and anchoring the annular
element includes pushing the one or more annular element tissue
anchors into tissue of the annulus.
For some applications:
inverting the cylindrical element includes advancing a prosthetic
valve along one or more valve guide members reversibly coupled to
the cylindrical element in a vicinity of the second end
thereof,
advancing the prosthetic valve includes advancing the prosthetic
valve into the ventricle to pull the guide members and the second
end of the cylindrical element into the ventricle, and
the method further includes following the advancing of the
prosthetic valve into the ventricle, pulling proximally the
prosthetic valve such that a proximal portion of the valve contacts
the valve support.
For some applications, pulling the prosthetic valve proximally
includes ensnaring the one or more leaflets of the valve by a
portion of the prosthetic valve.
There is also provided, in accordance with some applications of the
present invention, apparatus including a valve support for
receiving a prosthetic valve, the valve support including:
an annular element configured to be positioned along a native
annulus of a native atrioventricular valve of a patient, the
annular element having upper and lower surfaces; and
one or more annular element tissue anchors coupled to the lower
surface of the annular element, the one or more annular element
tissue anchors being configured to puncture tissue of the native
annulus of the patient.
For some applications, the valve support is collapsible for
transcatheter delivery and expandable to contact the native
atrioventricular valve.
For some applications, the one or more annular element tissue
anchors includes a plurality of annular element tissue anchors
positioned around the lower surface of the annular element.
For some applications, the one or more annular element tissue
anchors includes a first commissural annular element tissue anchor
configured to puncture tissue of the native valve at a first
commissure thereof, and a second commissural annular element tissue
anchor configured to puncture tissue of the native valve at a
second commissure thereof.
For some applications, each anchor of the one or more annular
element tissue anchors includes a distal pointed tip and one or
more radially-expandable prongs, the prongs being configured to
expand and facilitate anchoring of the anchor and restrict proximal
motion of the anchor.
For some applications, the apparatus includes one or more valve
support guide members configured to be delivered to one or more
commissures of the native atrioventricular valve of the patient,
the one or more valve support guide members are configured to
facilitate advancement of the valve support toward the native
valve.
For some applications, the valve support is shaped so as to define
one or more holes, the one or more holes configured to facilitate
slidable passage therethrough of a respective one of the one or
more valve support guide members.
For some applications, the one or more valve support guide members
includes one valve support guide member that is looped through
first and second commissures of the atrioventricular valve in a
manner in which a looped portion of the valve support guide member
is disposed in a ventricle of the patient and first and second free
ends of the valve support guide member are accessible from a site
outside a body of the patient.
For some applications, the apparatus includes one or more valve
support tissue anchors that are distinct from the valve support and
are configured to be advanceable along the one or more valve
support guide members and anchored to the one or more commissures
of the valve.
For some applications, the one or more valve support anchors
includes one or more ventricular anchors, and the apparatus further
includes one or more atrial anchors, each atrial anchor being
configured to be advanced toward an atrial surface of the valve
support and anchor in place the valve support in a vicinity of a
respective one of the ventricular anchors.
For some applications, the one or more valve support guide members
are removable from the patient following the anchoring of the valve
support at the atrioventricular valve.
For some applications, the one or more valve support tissue anchors
are configured to be anchored to the one or more commissures from
ventricular surfaces thereof prior to advancement of the valve
support.
For some applications, the one or more valve support tissue anchors
includes first and second valve support tissue anchors, the first
and second valve support tissue anchors being configured to be
anchored to respective first and second commissures of the
atrioventricular valve of the patient.
For some applications:
the one or more valve support tissue anchors each include one or
more radially-expandable prongs, and
the one or more prongs are disposed within a sheath in a compressed
state prior to the anchoring and exposed from within the sheath in
order to expand and facilitate anchoring of the anchor to the
respective commissures.
For some applications, the valve support further includes a
flexible generally cylindrical element coupled to the annular
element and configured to be positioned in the native
atrioventricular valve of the patient and to push aside native
leaflets of the native valve, the cylindrical element having first
and second ends and a cylindrical body that is disposed between the
first and second ends.
For some applications, the cylindrical element includes a flexible
wireframe covered by a fabric.
For some applications, the apparatus includes one or more
prosthetic valve guide members reversibly couplable to the
cylindrical element in a vicinity of the second end of the
cylindrical element, the prosthetic valve guide members being
configured to facilitate advancement of the prosthetic valve
therealong and toward the valve support.
For some applications, the apparatus includes the prosthetic valve,
and the prosthetic valve is couplable to the valve support.
For some applications: the first end of the cylindrical element is
coupled to the annular element, during a first period, the second
end of the cylindrical element is disposed above the annular
element in a manner in which the body of the cylindrical element is
disposed above the annular element, and the cylindrical element is
invertible in a manner in which, during a second period, the second
end of the cylindrical element is disposed below the annular
element and the body of the cylindrical element is disposed below
the annular element.
For some applications:
during the first period, the second end of the cylindrical element
is disposed in an atrium of a heart of the patient,
the prosthetic valve is advanceable along the one or more
prosthetic valve guide members into a ventricle of the heart of the
patient, and
in response to advancement of the prosthetic valve into the
ventricle, the one or more prosthetic valve guide members are
pulled into the ventricle and pull the second end of the
cylindrical element into the ventricle to invert the cylindrical
element.
There is additionally provided, in accordance with some
applications of the present invention, apparatus, including:
one or more valve support guide members configured to be delivered
to one or more commissures of a native atrioventricular valve of a
patient;
a prosthetic valve support configured to be advanced toward the
native valve along the one or more valve support guide members and
placed at the native valve;
a prosthetic valve configured to be coupled to the valve support;
and
one or more sealing elements configured to facilitate sealing of an
interface between the prosthetic valve support and the native
valve.
For some applications, the sealing element includes a balloon
disposed circumferentially around an outer surface of the
prosthetic valve support.
For some applications, the sealing element includes one or more
helices that are configured to facilitate sealing of commissures of
the native valve with respect to the valve support by being wrapped
around chordae tendineae of the native valve.
For some applications, the sealing element includes grasping
elements that are configured to facilitate sealing of commissures
of the native valve with respect to the valve support by grasping
the commissures.
For some applications, the sealing element is configured to
facilitate anchoring of the support to the native valve.
For some applications, the valve support is collapsible for
transcatheter delivery and expandable to contact the native
atrioventricular valve.
For some applications, the prosthetic valve includes two or more
prosthetic leaflets.
For some applications, the native atrioventricular valve includes a
mitral valve, and the prosthetic valve includes three prosthetic
leaflets.
For some applications, the valve support guide members are
removable from the patient following coupling of the prosthetic
valve to the valve support.
For some applications, the valve support is shaped so as to define
a distal portion which is configured to push aside, at least in
part, native leaflets of the valve of the patient.
For some applications, the valve support is shaped so as to define
one or more holes, the one or more holes being configured to
facilitate slidable passage therethrough of a respective one of the
one or more valve support guide members.
For some applications, the one or more valve support guide members
includes one valve support guide member that is looped through
first and second commissures of the atrioventricular valve in a
manner in which a looped portion of the valve support guide member
is disposed in a ventricle of the patient and first and second free
ends of the valve support guide member are accessible from a site
outside a body of the patient.
For some applications, the apparatus further includes:
a guide wire configured to be advanced, via the native
atrioventricular valve, into a ventricle of the patient, and
coupled to an inner wall of the patient's ventricle; and
a valve support guide member tube coupled to the guide wire,
and a distal portion of the valve support guide member is
configured to loop through the valve support guide member tube,
such that, in response to the valve support guide member being
pushed distally, portions of the valve support guide member are
pushed to respective commissures of the native valve.
For some applications, the prosthetic valve is shaped so as to
define one or more protrusions configured to ensnare one or more
native leaflets of the native valve of the patient.
For some applications, the protrusions are disposed in a sinusoidal
configuration such that the protrusions conform with a saddle shape
of the patient's native annulus.
For some applications, the protrusions are configured to prevent
the native leaflets from interfering with a left ventricular
outflow tract of the patient, by sandwiching the leaflets between
the protrusions and the prosthetic valve support.
For some applications, the valve support includes:
a first end that is configured to be placed on an atrial side of a
native atrioventricular valve of a patient; and
a second end that is configured, during a first period, to be
disposed inside the patient's atrium, above the first end of the
valve support,
the valve support being at least partially invertible in a manner
in which, during a second period, the second end of the valve
support is disposed at least partially inside a ventricle of the
patient, below the first end of the valve support.
For some applications, the valve support includes an annular
element and a generally cylindrical element coupled to the annular
element, the generally cylindrical element being configured to push
aside native leaflets of the native valve, and the cylindrical
element has first and second ends and a cylindrical body that is
disposed between the first and second ends.
For some applications, the sealing element includes a balloon
disposed underneath the annular element and configured to
facilitate sealing of an interface between the annular element and
the native valve.
For some applications, the apparatus further includes one or more
prosthetic valve guide members, the prosthetic valve guide members
being configured to facilitate advancement of the prosthetic valve
therealong and toward the valve support.
For some applications:
the first end of the cylindrical element is coupled to the annular
element,
during a first period, the second end of the cylindrical element is
disposed above the annular element in a manner in which the body of
the cylindrical element is disposed above the annular element,
and
the cylindrical element is invertible in a manner in which, during
a second period, the second end of the cylindrical element is
disposed below the annular element and the body of the cylindrical
element is disposed below the annular element.
For some applications:
during the first period, the second end of the cylindrical element
is disposed in an atrium of a heart of the patient and the annular
element is positioned along an annulus of the native valve,
the prosthetic valve is advanceable along the one or more
prosthetic valve guide members into a ventricle of the heart of the
patient, and
in response to advancement of the prosthetic valve into the
ventricle, the one or more prosthetic valve guide members are
pulled into the ventricle and pull the second end and the body of
the cylindrical element into the ventricle to invert the
cylindrical element.
There is further provided, in accordance with some applications of
the present invention, apparatus, including:
a prosthetic valve support configured to be advanced toward a
native atrioventricular valve of a patient and placed at the native
valve;
a prosthetic valve configured to be coupled to the valve support,
the prosthetic valve being shaped so as to define first and second
sets of one or more protrusions, each set of protrusions configured
to ensnare a respective native leaflet of the native valve of the
patient, the first set of protrusions being disposed within a first
circumferential arc with respect to a longitudinal axis of the
prosthetic valve, on a first side of a distal end of the prosthetic
valve, the second set of protrusions being disposed within a second
circumferential arc with respect to the longitudinal axis of the
prosthetic valve, on a second side of the distal end of the
prosthetic valve, the first and second sets being disposed so as to
provide first and second gaps therebetween at the distal end of the
prosthetic valve, at least one of the gaps having a circumferential
arc of at least 20 degrees; and
one or more valve guide members configured to be delivered to one
or more commissures of the native valve, and to guide the valve
such that the first and second circumferential arcs are aligned
with respective leaflets of the native valve and such that the
first and second gaps are aligned with respective commissures of
the native valve.
For some applications, the at least one of the gaps has a
circumferential arc of at least 60 degrees.
For some applications, the first circumferential arc defines an
angle of between 25 degrees and 90 degrees about the longitudinal
axis of the prosthetic valve.
For some applications, the second circumferential arc defines an
angle of between 25 degrees and 90 degrees about the longitudinal
axis of the prosthetic valve.
For some applications, the first circumferential arc defines an
angle of between 45 degrees and 75 degrees about the longitudinal
axis of the prosthetic valve.
For some applications, the second circumferential arc defines an
angle of between 45 degrees and 75 degrees about the longitudinal
axis of the prosthetic valve.
There is additionally provided, in accordance with some
applications of the present invention, a method, including:
determining an area defined by an annulus of a native
atrioventricular valve of a patient;
selecting a prosthetic valve to be placed in the native valve by
determining that the valve defines a cross-sectional area that is
less than 90% of the area defined by the annulus; and
deploying the prosthetic valve at the native valve,
the selecting of the prosthetic valve facilitating sealing of the
native valve with respect to the prosthetic valve by facilitating
closing of leaflets of the native valve around the prosthetic
valve, upon deployment of the prosthetic valve.
For some applications, selecting the prosthetic valve includes
selecting a prosthetic valve having a material disposed on an outer
surface thereof.
For some applications, selecting the prosthetic valve includes
selecting a prosthetic valve having a material that prevents tissue
growth disposed on an outer surface thereof.
For some applications, selecting the prosthetic valve includes
selecting a prosthetic valve having a material that promotes tissue
growth disposed on an outer surface thereof.
For some applications, selecting the prosthetic valve to be placed
in the native valve includes determining that the valve defines a
cross-sectional area that is less than 80% of the area defined by
the annulus.
For some applications, selecting the prosthetic valve to be placed
in the native valve includes determining that the valve defines a
cross-sectional area that is less than 60% of the area defined by
the annulus.
There is further provided, in accordance with some applications of
the present invention, apparatus including:
a valve support for receiving a prosthetic valve, the valve support
including: a first end that is configured to be placed on an atrial
side of a native atrioventricular valve of a patient; and a second
end that is configured, during a first period, to be disposed
inside the patient's atrium, above the first end of the valve
support, the valve support being at least partially invertible in a
manner in which, during a second period, the second end of the
cylindrical element is disposed at least partially inside a
ventricle of the patient, below the first end of the valve
support.
For some applications, the valve support includes a flexible
wireframe covered by a fabric.
For some applications, the valve support is collapsible for
transcatheter delivery and expandable to contact the native
atrioventricular valve.
For some applications, the valve support defines a surface that is
an inner surface of the valve support during the first period, and
an outer surface of the valve support during the second period, and
the apparatus further includes a sealing material that is disposed
on the surface, such that during the second period the sealing
material facilitates sealing between the valve support and the
native valve.
For some applications, the first end includes a coupling element
configured to couple the valve support to tissue of the native
valve on the atrial side of the native valve.
For some applications, the first end is shaped to define barbs that
are configured to couple the valve support to tissue of the native
valve on the atrial side of the native valve
For some applications, the valve support includes:
an annular element configured to be positioned along a native
annulus of the native atrioventricular valve; and
a flexible generally cylindrical element configured to be
positioned in the native atrioventricular valve of the patient and
to push aside native leaflets of the native valve, the first end of
the cylindrical element defining the first end of the valve
support, and the first end of the cylindrical element being coupled
to the annular element.
For some applications, the apparatus further includes one or more
valve support guide members configured to be delivered to one or
more commissures of the native atrioventricular valve of the
patient, and the one or more valve support guide members are
configured to facilitate advancement of the valve support toward
the native valve.
For some applications, the valve support is shaped so as to define
one or more holes, the one or more holes configured to facilitate
slidable passage therethrough of a respective one of the one or
more valve support guide members.
For some applications, the one or more valve support guide members
includes one valve support guide member that is looped through
first and second commissures of the atrioventricular valve in a
manner in which a looped portion of the valve support guide member
is disposed in a ventricle of the patient and first and second free
ends of the valve support guide member are accessible from a site
outside a body of the patient.
For some applications, the apparatus further includes:
a guide wire configured to be advanced, via the native
atrioventricular valve, into a ventricle of the patient, and
coupled to an inner wall of the patient's ventricle; and
a valve support guide member tube coupled to the guide wire,
and a distal portion of the valve support guide member is
configured to loop through the valve support guide member tube,
such that, in response to the valve support guide member being
pushed distally, portions of the valve support guide member are
pushed to respective commissures of the native valve.
For some applications, the apparatus further includes one or more
prosthetic valve guide members reversibly couplable to the
cylindrical element in a vicinity of the second end of the
cylindrical element, the prosthetic valve guide members being
configured to facilitate advancement of the prosthetic valve
therealong and toward the valve support.
For some applications, the apparatus further includes the
prosthetic valve, and the prosthetic valve is couplable to the
valve support.
For some applications:
during the first period, the second end of the cylindrical element
is disposed in an atrium of a heart of the patient and the annular
element is positioned along an annulus of the native valve,
the prosthetic valve is advanceable along the one or more
prosthetic valve guide members into a ventricle of the heart of the
patient, and
in response to advancement of the prosthetic valve into the
ventricle, the one or more prosthetic valve guide members are
pulled into the ventricle and pull the second end of the
cylindrical element into the ventricle to invert the cylindrical
element.
For some applications, the apparatus further includes one or more
sealing elements configured to facilitate sealing of an interface
between the prosthetic valve support and the native valve.
For some applications, the sealing element includes a balloon
disposed circumferentially around a surface of the prosthetic valve
support.
For some applications, the sealing element includes one or more
helices that are configured to facilitate sealing of commissures of
the native valve with respect to the valve support by being wrapped
around chordae tendineae of the native valve.
For some applications, the sealing element includes grasping
elements that are configured to facilitate sealing of commissures
of the native valve with respect to the valve support by grasping
the commissures.
For some applications, the sealing element is configured to
facilitate anchoring of the support to the native valve.
For some applications, the apparatus further includes the
prosthetic valve, and the prosthetic valve is couplable to the
valve support.
For some applications, the prosthetic valve is collapsible for
transcatheter delivery and expandable when exposed from within a
delivery catheter.
For some applications, the prosthetic valve includes two or more
prosthetic leaflets.
For some applications, the native atrioventricular valve includes a
mitral valve, and the prosthetic valve includes three prosthetic
leaflets.
For some applications, the prosthetic valve is shaped so as to
define one or more protrusions configured to ensnare one or more
native leaflets of the native valve of the patient.
For some applications, the protrusions are disposed in a sinusoidal
configuration such that the protrusions conform with a saddle shape
of the patient's native annulus.
For some applications, the protrusions are configured to prevent
the native leaflets from interfering with a left ventricular
outflow tract of the patient, by sandwiching the leaflets between
the protrusions and the prosthetic valve support.
There is further provided, in accordance with some applications of
the present invention, apparatus, including:
a guide wire configured to be advanced into a patient's ventricle
via a native atrioventricular valve of the patient, and coupled to
an inner wall of the patient's ventricle;
a valve support guide member tube coupled to the guide wire;
a valve support guide member, a distal portion of the valve support
guide member looping through the valve support guide member tube,
such that, in response to the valve support guide member being
pushed distally, portions of the valve support guide member are
pushed to respective commissures of the native valve;
a prosthetic valve support configured to be advanced toward the
commissures of the native valve along the valve support guide
member portions; and
a prosthetic valve configured to be coupled to the valve
support.
For some applications, first and second free ends of the valve
support guide member are accessible from a site outside a body of
the patient.
For some applications, the valve support includes:
an annular element configured to be positioned along a native
annulus of the native atrioventricular valve; and
a generally cylindrical element configured to be positioned in the
native atrioventricular valve of the patient and to push aside
native leaflets of the native valve, the cylindrical element being
coupled to the annular element, at a first end of the cylindrical
element.
For some applications, the valve support is shaped so as to define
one or more holes, the one or more holes configured to facilitate
slidable passage therethrough of respective portions of the
portions of the valve support guide member.
For some applications, the guide member is configured to facilitate
advancement of the prosthetic valve therealong and toward the valve
support.
For some applications, the prosthetic valve is collapsible for
transcatheter delivery and expandable when exposed from within a
delivery catheter.
For some applications, the prosthetic valve includes two or more
prosthetic leaflets.
For some applications, the native atrioventricular valve includes a
mitral valve, and the prosthetic valve includes three prosthetic
leaflets.
For some applications, the guide member is removable from the
patient following the coupling of the prosthetic valve to the valve
support.
For some applications, the prosthetic valve is shaped so as to
define one or more protrusions configured to ensnare one or more
native leaflets of the native valve of the patient.
For some applications, the protrusions are disposed in a sinusoidal
configuration such that the protrusions conform with a saddle shape
of the patient's native annulus.
For some applications, the protrusions are configured to prevent
the native leaflets from interfering with a left ventricular
outflow tract of the patient, by sandwiching the leaflets between
the protrusions and the prosthetic valve support.
For some applications, the apparatus further includes one or more
sealing elements configured to facilitate sealing of an interface
between the prosthetic valve support and the native valve.
For some applications, the sealing element includes a balloon
disposed circumferentially around a surface of the prosthetic valve
support.
For some applications, the sealing element includes one or more
helices that are configured to facilitate sealing of commissures of
the native valve with respect to the valve support by being wrapped
around chordae tendineae of the native valve.
For some applications, the sealing element includes grasping
elements that are configured to facilitate sealing of commissures
of the native valve with respect to the valve support by grasping
the commissures.
For some applications, the sealing element is configured to
facilitate anchoring of the support to the native valve.
There is additionally provided, in accordance with some
applications of the present invention, apparatus, including:
one or more valve guide members configured to be delivered to one
or more commissures of a native atrioventricular valve of a
patient;
a prosthetic valve configured to be advanced to be advanced toward
the native valve along the one or more valve guide members and
placed at the native valve at at least the one or more commissures;
and
one or more proximally-facing grasping elements that are configured
to facilitate sealing of commissures of the native valve with
respect to the valve by: being inserted into a ventricle of the
patient; and being pulled proximally and being closed around tissue
in a vicinity of the commissures.
For some applications, the grasping elements include two surfaces
that are hingedly coupled to one another, and that are configured
to facilitate the sealing of the commissures of the native valve
with respect to the prosthetic valve by being closed about the
hinge with respect to one another.
There is further provided, in accordance with some applications of
the present invention, a method, including:
advancing one or more valve support guide members toward one or
more commissures of a native atrioventricular valve of a
patient;
placing a prosthetic valve support at the native atrioventricular
valve by advancing the valve support along the one or more valve
support guide members;
coupling a prosthetic valve to the prosthetic valve support;
and
facilitating sealing of an interface between the prosthetic valve
support and the native valve by deploying a sealing element in a
vicinity of the interface.
There is additionally provided, in accordance with some
applications of the present invention, a method including:
placing a first end of a prosthetic valve support on an atrial side
of a native atrioventricular valve of a patient, such that a second
end of the valve support is disposed, during a first period, inside
the patient's atrium, above the first end of the valve support;
and
subsequent to the placing of the valve support, inverting at least
a portion of the valve support such that, during a second period,
the second end of the valve support is disposed at least partially
inside a ventricle of the patient, below the first end of the valve
support.
There is additionally provided, in accordance with some
applications of the present invention, a method, including:
advancing a guide wire, via a native atrioventricular valve, into a
ventricle of the patient, a valve support guide member tube being
coupled to the guide wire;
coupling a distal end of the guide wire to an inner wall of the
patient's ventricle; and
causing portions of a valve support guide member to be pushed to
respective commissures of the native valve, by pushing the guide
member distally, a distal portion of the valve support guide member
looping through the valve support guide member tube;
advancing a prosthetic valve support toward the commissures of the
native valve along the valve support guide member portions; and
coupling a prosthetic valve to the valve support.
There is further provided, in accordance with some applications of
the present invention, a method, including:
advancing one or more valve guide members toward one or more
commissures of a native atrioventricular valve of a patient;
placing a prosthetic valve at the native atrioventricular valve by
advancing the valve along the one or more valve guide members;
and
facilitating sealing of commissures of the native valve with
respect to the valve by: inserting into a ventricle of the patient
one or more grasping elements that are coupled to the prosthetic
valve; pulling the grasping elements proximally; and closing the
grasping elements around tissue in a vicinity of the
commissures.
The present invention will be more fully understood from the
following detailed description of embodiments thereof, taken
together with the drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1A-B are schematic illustrations of advancement of one or
more guide members toward respective commissures of a mitral valve,
in accordance with some applications of the present invention;
FIGS. 1C-D are schematic illustrations of the advancement and
deployment of commissural anchors via the guide members, in
accordance with some applications of the present invention;
FIGS. 2A-D are schematic illustrations of the advancement of a
prosthetic valve support toward a native atrioventricular valve of
a patient, in accordance with some applications of the present
invention;
FIGS. 2E-F are schematic illustrations of locking of the prosthetic
valve support at the native valve, in accordance with some
applications of the present invention;
FIGS. 2G-K are schematic illustrations of the advancement of a
prosthetic valve and the coupling of the prosthetic valve to the
valve support, in accordance with some applications of the present
invention;
FIGS. 3A-B are schematic illustrations of the advancement of a
prosthetic valve support toward a native atrioventricular valve of
a patient, the valve support including a sealing balloon, in
accordance with some applications of the present invention;
FIGS. 3C-D are schematic illustrations of locking of the prosthetic
valve support at the native valve, the valve support including the
sealing balloon, in accordance with some applications of the
present invention;
FIGS. 4A-C are schematic illustrations of a valve support being
used with commissural helices that facilitate anchoring and/or
sealing of the valve support, in accordance with some applications
of the present invention;
FIGS. 5A-D are schematic illustrations of grasping elements being
used to anchor and/or provide sealing of a prosthetic valve, in
accordance with some applications of the present invention;
FIGS. 6A-B are schematic illustrations of a prosthetic valve that
includes a sealing material, in accordance with some applications
of the present invention;
FIGS. 7A-F are schematic illustrations of a guide wire delivery
system, in accordance with some applications of the present
invention;
FIGS. 8A-C are schematic illustrations of a valve support that has
a cylindrical element that is invertible, in accordance with some
applications of the present invention;
FIGS. 9A-D are schematic illustrations of the advancement of an
invertible prosthetic valve support toward a native
atrioventricular valve of a patient, in accordance with some
applications of the present invention;
FIG. 9E is a schematic illustration of inversion of the invertible
prosthetic valve support at the native valve, in accordance with
some applications of the present invention;
FIGS. 9F-H are schematic illustrations of the advancement of a
prosthetic valve and the coupling of the prosthetic valve to the
invertible valve support, in accordance with some applications of
the present invention;
FIG. 10 is a schematic illustration of a prosthetic valve, the
cross-sectional area of which is smaller than the area defined by
the patient's native valve annulus, in accordance with some
applications of the present invention;
FIGS. 11A-D are schematic illustrations of a prosthetic valve that
defines protrusions from portions of the distal end of the valve,
in accordance with some applications of the present invention;
FIGS. 12A-C are schematic illustrations of a prosthetic valve that
defines distal protrusions that are disposed sinusoidally around
the circumference of the valve, in accordance with some
applications of the present invention;
FIGS. 13A-E are schematic illustrations of respective
configurations of a frame of a prosthetic valve, in accordance with
some applications of the present invention;
FIGS. 14A-D are schematic illustrations of respective
configurations of a prosthetic valve support, in accordance with
some applications of the present invention;
FIGS. 15A-E are schematic illustrations of respective steps of a
procedure for deploying a prosthetic valve, in accordance with some
applications of the present invention;
FIGS. 16A-H are schematic illustrations of respective steps of an
alternative procedure for deploying a prosthetic valve, in
accordance with some applications of the present invention;
FIGS. 17A-C are schematic illustrations of leaflets of a prosthetic
valve, in accordance with some applications of the present
invention;
FIGS. 18A-B are schematic illustrations of a valve support coupled
to a plurality of tissue anchors, in accordance with some
applications of the present invention;
FIGS. 19A-D are schematic illustrations of the valve support of
FIGS. 18A-B being implanted in the native valve of the patient and
facilitating implantation of a prosthetic valve, in accordance with
some applications of the present invention; and
FIGS. 20A-B are schematic illustrations of a prosthetic valve and a
prosthetic valve support deployed, respectively, at a tricuspid
valve, and at an aortic valve, in accordance with some applications
of the present invention.
DETAILED DESCRIPTION OF THE EMBODIMENTS
Reference is now made to FIGS. 1A-B, which are schematic
illustrations of a system 20 for replacing an atrioventricular
valve 5 of a patient comprising one or more guide members 21a and
21b which are advanced toward first and second commissures 8 and 10
of valve 5 of a heart 2 of the patient, in accordance with some
applications of the present invention. For some applications, guide
members 21a and 21b comprise distinct guide members. Alternatively
(as shown in FIGS. 7A-F), only one guide member is looped through
commissures 8 and 10 in a manner in which the guide member defines
a looped portion between commissures 8 and 10 (i.e., a portion of
the guide member that is disposed in a ventricle 6 of heart 2), and
first and second free ends which are disposed and accessible at a
site outside the body of the patient. For such applications, the
guide member defines portions 21a and 21b.
It is noted that for applications in which valve 5 is the patient's
mitral valve, first and second commissures 8 and 10 are the
anterior and posterior commissures. For applications in which valve
5 is the patient's tricuspid valve (which includes three
commissures), the first and second commissures are typically the
anterior and posterior commissures of the tricuspid valve.
For some applications, guide members 21a and 21b comprise guide
wires having a diameter of 0.035 inches.
The transcatheter procedure typically begins with the advancing of
a semi-rigid guide wire into a right atrium 4 of the patient. The
semi-rigid guide wire provides a guide for the subsequent
advancement of a sheath 25 therealong and into the right atrium.
Once sheath 25 has entered the right atrium, the semi-rigid guide
wire is retracted from the patient's body. Sheath 25 typically
comprises a 13-20 F sheath, although the size may be selected as
appropriate for a given patient. Sheath 25 is advanced through
vasculature into the right atrium using a suitable point of origin
typically determined for a given patient. For example: sheath 25
may be introduced into the femoral vein of the patient, through an
inferior vena cava, into the right atrium, and into the left atrium
transseptally, typically through the fossa ovalis; sheath 25 may be
introduced into the basilic vein, through the subclavian vein to
the superior vena cava, into the right atrium, and into the left
atrium transseptally, typically through the fossa ovalis; or sheath
25 may be introduced into the external jugular vein, through the
subclavian vein to the superior vena cava, into the right atrium,
and into the left atrium transseptally, typically through the fossa
ovalis.
In some applications of the present invention, sheath 25 is
advanced through the inferior vena cava of the patient and into the
right atrium using a suitable point of origin typically determined
for a given patient.
Sheath 25 is advanced distally until sheath 25 reaches the
interatrial septum. For some applications, a resilient needle and a
dilator (not shown) are advanced through the sheath and into the
heart. In order to advance the sheath transseptally into the left
atrium, the dilator is advanced to the septum, and the needle is
pushed from within the dilator and is allowed to puncture the
septum to create an opening that facilitates passage of the dilator
and subsequently the sheath therethrough and into the left atrium.
The dilator is passed through the hole in the septum created by the
needle. Typically, the dilator is shaped to define a hollow shaft
for passage along the needle, and the hollow shaft is shaped to
define a tapered distal end. This tapered distal end is first
advanced through the hole created by the needle. The hole is
enlarged when the gradually increasing diameter of the distal end
of the dilator is pushed through the hole in the septum.
The advancement of sheath 25 through the septum and into the left
atrium is followed by the extraction of the dilator and the needle
from within sheath 25.
FIGS. 1C-D and 2A-B show advancement of one or more tissue anchors
30a and 30b along guide members 21a and 21b, respectively. Anchors
30a and 30b comprise a flexible, biocompatible material (e.g.,
nitinol) and comprise one or more (e.g., a plurality of)
radially-expandable prongs 32 (e.g., barbs). Each anchor 30a and
30b is reversibly coupled to a respective delivery lumen 27a and
27b. Each delivery lumen 27 slides around a respective guide member
21. A respective surrounding sheath 26a and 26b surrounds each
delivery lumen 27a and 27b and around anchors 30a and 30b at least
in part in order to compress and prevent expansion of prongs 32 of
tissue anchors 30a and 30b.
As shown in FIG. 1D, the distal ends of lumens 27a and 27b are
reversibly coupled to ribbed crimping structures 34. As described
hereinbelow, anchors 30a and 30b are anchored to ventricular
surfaces of commissures 8 and 10. Following the anchoring, ribbed
crimping structures 34 extend from anchors 30a and 30b through
commissures 8 and 10, respectively, and toward the atrial surfaces
of commissures 8 and 10. Ribbed crimping structures 34 are
configured to facilitate anchoring of a valve support (described
hereinbelow) to the atrial surfaces of commissures 8 and 10.
Anchors 30a and 30b, ribbed crimping structures 34, and the distal
ends of surrounding sheaths 26a and 26b are advanced into ventricle
6. Subsequently, anchors 30a and 30b are pushed distally from
within sheaths 26a and 26b, (or sheaths 26a and 26b are pulled
proximally with respect to anchors 30a and 30b) to expose anchors
30a and 30b. As anchors 30a and 30b are exposed from within sheaths
26a and 26b, prongs 32 are free to expand, as shown in FIG. 1D.
Prongs 32 expand such that anchors 30a and 30b assume a flower
shape. Prongs 32, collectively in their expanded state, create a
larger surface area to engage tissue than in their compressed
states. Following the exposing of anchors 30a and 30b, sheaths 26a
and 26b are extracted.
As shown in FIG. 2B, lumens 27a and 27b are pulled proximally so
that prongs 32 of anchors 30a and 30b engage respective ventricular
surface of commissures 8 and 10. Prongs 32 create a large surface
area which restricts proximal motion of anchors 30a and 30b from
commissures 8 and 10, respectively.
For some applications, following the anchoring of anchors 30a and
30b to commissures 8 and 10, respectively, guide members 21a and
21b are removed from the body of the patient.
Reference is now made to FIGS. 2C-F, which are schematic
illustrations of the advancement of a prosthetic valve support 40
along lumens 27a and 27b, in accordance with some applications of
the present invention. In such a manner, lumens 27a and 27b
function as valve support guide members. Support 40 comprises a
collapsible skirt having a proximal annular element 44 and a distal
cylindrical element 42. Support 40 is configured to assume a
collapsed state (e.g., surrounded by a sheath or overtube 50 shown
in FIG. 2C) for minimally-invasive delivery to the diseased native
valve, such as by percutaneous or transluminal delivery using one
or more catheters. FIG. 2C and the other figures show support 40 in
an expanded state after delivery in right atrium 4 and advancement
toward the native valve. As shown in FIG. 2D, support 40 is shaped
so as to define one or more (e.g., two, as shown in View A) holes
46a and 46b for slidable advancement of support 40 along lumens 27a
and 27b, respectively. That is, prior to introduction of support 40
into the body of the patient, lumens 27a and 27b are threaded
through holes 46a and 46b, respectively, and support 40 is slid
along lumens 27a and 27b. Support 40 is slid by pushing elements
52a and 52b which surround delivery lumens 27a and 27b,
respectively.
It is to be noted that support 40 is slid along lumens 27a and 27b
by way of illustration and not limitation. That is, for some
applications, following the anchoring of anchors 30a and 30b to
commissures 8 and 10, respectively, guide members 21a and 21b are
not removed from the body of the patient, but rather lumens 27a and
27b are removed (e.g., by being decoupled from crimping structures
34) leaving behind anchors 30a and 30b and guide members 21a and
21b. Guide members 21a and 21b may then be threaded through holes
46a and 46b, respectively, and support 40 is slid along guide
members 21a and 21b. In such a manner, guide members 21a and 21b
function as valve support guide members.
Support 40 comprises a collapsible flexible support frame 48, which
is at least partially covered by a covering 49. Support 40 is
configured to be placed at native valve 5, such that cylindrical
element 42 passes through the orifice of the native valve and
extends towards, and, typically partially into, ventricle 6 (as
shown in FIG. 2E). Cylindrical element 42 typically pushes aside
and presses against native leaflets of native valve 5 at least in
part, which are left in place during and after implantation of the
prosthetic valve. Annular element 44 is configured to be placed
around a native annulus 11 of the native valve, and to extend at
least partially into an atrium 4 such that annular element 44 rests
against the native annulus. Annular element 44 is typically too
large to pass through the annulus, and may, for example, have an
outer diameter of between 30 and 60 mm.
For some applications, collapsible support frame 48 comprises a
stent, which comprises a plurality of struts. The struts may
comprise, for example, a metal such as nitinol or stainless steel.
For some applications, frame 48 comprises a flexible metal, e.g.,
nitinol, which facilitates compression of support 40 within a
delivery sheath or overtube 50. For some applications, covering 49
comprises a fabric, such as a woven fabric, e.g., Dacron. Covering
49 is typically configured to cover at least a portion of
cylindrical element 42, and at least a portion of annular element
44. The covering may comprise a single piece, or a plurality of
pieces sewn together.
As shown in FIG. 2D, pushing elements 52a and 52b are each coupled
to locking crimping elements 64a and 64b, respectively. Locking
crimping elements 64a and 64b are disposed adjacently, proximally
to holes 46a and 46b respectively of valve support 40. These
techniques enable the surgeon to readily bring crimping elements
64a and 64b to the appropriate sites along annular element 44,
without the need for excessive imaging, such as fluoroscopy.
FIG. 2E shows valve support 40 prior to implantation at annulus 11.
As shown, ribbed crimping structures 34 project away from anchors
30a and 30b, through commissures 8 and 10, and toward atrium 4.
Valve support 40 is advanced along lumens 27a and 27b toward
structures 34 by being pushed by pushing elements 52a and 52b and
locking crimping elements 64a and 64b.
In FIG. 2F, valve support 40 is further pushed by pushing elements
52a and 52b and locking crimping elements 64a and 64b such holes
46a and 46b of support 40 advance around ribbed crimping structures
34. As holes 46a and 46b are advanced around ribbed crimping
structures 34, locking crimping elements 64a and 64b advance over
and surround ribbed crimping elements 34 to lock in place valve
support 40 from an atrial surface of valve 5.
Responsively to the placement of valve support 40 at native valve
5, cylindrical element 42 is positioned partially within ventricle
6 and native leaflets 12 and 14 of native valve 5 are pushed
aside.
As shown in section A-A, ribbed crimping structures 34 are shaped
so as to define a plurality of male couplings. Locking crimping
elements 64a and 64b each comprise a cylindrical element having an
inner lumen that is shaped so as to surround a respective ribbed
crimping structure 34. Each inner lumen of locking crimping
elements 64a and 64b is shaped so as to define female couplings to
receive the male couplings of ribbed crimping structure 34. The
female couplings of locking crimping element 64 are directioned
such that they facilitate distal advancement of locking crimping
element 64 while restricting proximal advancement of locking
crimping element 64. When the female couplings of locking crimping
element 64 receive the male couplings of ribbed crimping structure
34, valve support 40 is locked in place from an atrial surface of
valve 5. It is to be noted that for some applications, ribbed
crimping elements 34 comprise female couplings, and locking
crimping elements 64 comprise male couplings.
Reference is now made to FIGS. 2G-K which are schematic
illustrations of the coupling of a prosthetic atrioventricular
valve 80 to valve support 40, in accordance with some applications
of the present invention. Support 40 receives the prosthetic valve
and functions as a docking station. Thus, the docking station is a
coupling element that provides coupling between two other elements
(in this case, between annulus 11 and the prosthetic valve.)
Following the placement of support 40 at annulus 11, pushing
elements 52a and 52b and sheath or overtube 50 are removed from the
body of the patient, leaving behind lumens 27a and 27b, as shown in
FIG. 2G.
As shown in FIG. 2G, a guide wire 72 is advanced toward ventricle 6
and facilitates the advancement of an overtube 70 through sheath 25
and the positioning of a distal end of overtube 70 within ventricle
6. Overtube 70 facilitates the advancement of prosthetic valve 80
in a compressed state, toward valve support 40.
FIG. 2H shows partial deployment of valve 80 within ventricle 6 of
heart 2. Valve 80 is shown comprising an expandable frame 79
comprising a plurality of stent struts by way of illustration and
not limitation. The wireframe of valve 80 comprises a flexible
metal, e.g., nitinol or stainless steel. It is to be noted that the
wireframe of valve 80 is covered by a covering (not shown for
clarity of illustration) comprising a braided mesh or in a fabric
such as a woven fabric, e.g., Dacron. The covering is typically
configured to cover at least a portion of the frame. The covering
may comprise a single piece, or a plurality of pieces sewn
together. Expandable frame 79 is typically self-expandable,
although the scope of the present invention includes using a
prosthetic valve that includes a balloon expandable frame, mutatis
mutandis.
Following the partial deployment of valve 80 in ventricle 6,
overtube 70 is pulled proximally to pull valve 80 proximally such
that cylindrical element 42 and/or annular element 44 of valve
support 40 surrounds a proximal portion of prosthetic valve 80.
Valve 80 has a tendency to expand such that valve 80 is held in
place with respect to valve support 40 responsively to radial
forces acted upon valve support 40 by prosthetic valve 80.
Valve 80 comprises a plurality of distal protrusions 84 (e.g.,
snares). When valve 80 is pulled proximally, as described
hereinabove, protrusions 84 ensnare and engage the native leaflets
of the atrioventricular valve. By the ensnaring of the native
leaflets, protrusions 84 sandwich the native valve between
protrusions 84 and prosthetic valve support 40. Such ensnaring
helps further anchor prosthetic valve 80 to the native
atrioventricular valve. The scope of the present invention includes
using any sort of protrusions (e.g., hooks) that protrude from the
distal end of expandable frame 79 of prosthetic valve 80 and that
are configured such that the native valve is sandwiched between the
protrusions and valve support 40. Typically, the protrusions cause
sandwiching of the native valve leaflets, such that the leaflets do
not interfere with the left ventricular outflow tract (LVOT).
For some applications, protrusions 84 are such as to (a) prevent
proximal migration of the valve into the patient's atrium, while
(b) allowing movement of the native leaflets with respect to the
frame of the prosthetic valve. For example, the protrusions may
have the aforementioned functionalities by having lengths of less
than 5 mm, and/or by a total width of each set of protrusions
corresponding to respective leaflets of the native valve being less
than 5 mm. For example, the valve may include a single protrusion
corresponding to each leaflet of the native valve, the width of
each of the single protrusions being less than 1 mm. Thus, the
valve may be stopped from proximally migrating into the atrium, by
the protrusions preventing the distal end of the valve from
migrating further proximally than edges of native leaflets of the
valve. Furthermore, the protrusions may allow movement of the
native leaflets with respect to the frame of the prosthetic valve
by not generally squeezing the native leaflets between the
protrusions and the frame of the valve. For some applications, by
allowing movement of the native leaflets with respect to the frame
of the prosthetic valve, sealing of the native leaflets against the
outer surface of the frame of the prosthetic valve is facilitated,
in accordance with the techniques described hereinbelow with
reference to FIG. 10. Typically, valve support 40 prevents the
valve from migrating distally into the patient's ventricle.
For some applications, during the procedure, the prosthetic valve
is pulled back proximally with respect to valve support, as
described hereinabove. The prosthetic valve is pulled back to a
position with respect to valve support that is such that
protrusions 84 prevent the native leaflets from interfering with
the LVOT, by sandwiching the native leaflets between the
protrusions and the valve support, and/or by anchoring ends of the
native leaflets as described hereinabove. The prosthetic valve is
then deployed at this position.
For some applications, protrusions are disposed on the valve on the
sides of the valve that are adjacent to the anterior and posterior
leaflets of the native valve, and the valve does not includes
protrusions on the portions of the valve that are adjacent to the
commissures of the native valve, as described with reference to
FIGS. 11A-D. For some applications, the protrusions are disposed in
a sinusoidal configuration in order to conform with the saddle
shape of the native valve, as described hereinbelow with reference
to FIGS. 12A-C.
Additionally, as shown in FIG. 2J, valve 80 comprises one or more
(e.g., a plurality, as shown) coupling elements 81 at the proximal
end of valve 80. Overtube 70, which facilitates the advancement of
prosthetic valve 80, is reversibly coupled to valve 80, via
coupling elements 81.
Prosthetic valve 80 is configured for implantation in and/or at
least partial replacement of a native atrioventricular valve 5 of
the patient, such as a native mitral valve or a native tricuspid
valve. Prosthetic valve 80 is configured to assume a collapsed
state for minimally-invasive delivery to the diseased native valve,
such as by percutaneous or transluminal delivery using one or more
catheters. FIG. 2J shows prosthetic valve 80 in an expanded state
after delivery to the native valve.
Reference is now made to FIG. 2K which shows a bird's-eye view of
valve 80. Prosthetic valve 80 further comprises a plurality of
valve leaflets 82, which may be artificial or tissue-based. The
leaflets are typically coupled to an inner surface of the valve
prosthesis. Leaflets 82 are coupled, e.g., sewn, to expandable
frame 79 and/or to the covering. For applications in which the
prosthetic valve is configured to be implanted at the native mitral
valve, the prosthetic valve typically comprises three leaflets 82a,
82b, and 82c, as shown in FIG. 2K.
Reference is now made to FIGS. 3A-D, which are schematic
illustrations of the advancement of prosthetic valve support 40
toward native atrioventricular valve 5 of a patient, the valve
support including a sealing balloon 90, in accordance with some
applications of the present invention. The steps shown in FIGS.
3A-C are generally similar to those shown in FIGS. 2C-F. For some
applications, sealing balloon 40 is disposed on the valve-facing,
lower side of annular element 44 of the prosthetic valve support.
FIG. 3D shows valve support 40, the valve support having been
implanted at annulus 11. Typically, at this stage, balloon 40 is
inflated, as shown in the transition from FIG. 3C to FIG. 3D. The
balloon is inflated via an inflation lumen 92, shown in FIG. 3C,
for example. For some applications, the balloon seals the interface
between the prosthetic valve support and native annulus 11, thereby
reducing retrograde blood flow from ventricle 6 into atrium 4,
relative to retrograde blood flow in the absence of a sealing
balloon. For some applications, the balloon is inflated prior to
the placement of the prosthetic support at annulus 11.
Reference is now made to FIGS. 4A-C, which are schematic
illustrations of prosthetic valve support 40 being used with
commissural helices 100a and 100b that facilitate anchoring and/or
sealing of the valve support, in accordance with some applications
of the present invention. For some applications, commissural
helices are used as an alternative or in addition to anchors 30a
and 30b and/or other anchoring elements described herein, in order
to facilitate the anchoring of valve support 40.
Commissural helices 100a and 100b are typically placed at
commissures 8 and 10 in a generally similar technique to that
described with reference to anchors 30a and 30b. Typically, each
helix 30a and 30b is reversibly coupled to a respective delivery
lumen 27a and 27b. As described above, each delivery lumen 27
slides around a respective guide member 21, and a respective
surrounding sheath 26a and 26b surrounds each delivery lumen 27a
and 27b.
Commissural helices 100a and 100b (optionally, ribbed crimping
structures 34), and the distal ends of surrounding sheaths 26a and
26b are advanced into ventricle 6. The helices are pushed out of
the distal ends of surrounding sheaths 26a and 26b. Subsequently,
the helices are rotated proximally such that the helices wrap
around at least some chordae tendineae 102 of the patient.
Following the advancement of the helices out of sheaths 26a and
26b, the sheaths are extracted. For some applications the helices
are conical helices (as shown), and the wider end of the conical
helix is disposed at the proximal end of the helix.
Subsequent to the placement of commissural helices 100a and 100b
around the chordae tendineae, prosthetic valve support 40 is placed
at annulus 11, in accordance with the techniques described
hereinabove, and as shown in FIG. 4B. Subsequently, prosthetic
valve 80 is coupled to the prosthetic valve support, in accordance
with the techniques described hereinabove, and as shown in FIG.
4C.
Typically, commissural helices 100a and 100b facilitate sealing of
native commissures 8 and 10, thereby reducing retrograde blood flow
via the commissures, relative to retrograde blood flow in the
absence of the helices. Further typically, the sealing of the
native commissures facilitates anchoring of the prosthetic valve
support to native valve 5.
Reference is now made to FIGS. 5A-D, which are schematic
illustrations of grasping elements 106a and 106b being used to
anchor prosthetic valve 80, in accordance with some applications of
the present invention. For some applications, guide members 21a and
21b are advanced toward first and second commissures 8 and 10 of
valve 5 of the patient, as described hereinabove. Grasping elements
106a and 106b are reversibly coupled to distal ends of delivery
lumen 27a and 27b, the delivery lumens being advanced over
respective guide members, as described hereinabove. For some
applications, the guiding members and the grasping elements are
advanced toward the patient's commissures via surrounding sheaths
26a and 26b, the surrounding sheaths being generally as described
hereinabove. The grasping elements are typically placed distally to
the commissures in a proximally-facing configuration, as shown in
FIG. 5A. For example, as shown, the grasping elements may be
configured to be proximally facing due to the coupling of the
grasping elements to the guide members.
Subsequent to the placement of grasping elements 106a and 106b
distally to native commissures 8 and 10, prosthetic valve 80 is
advanced toward native valve 5, as shown in FIG. 5B. For example,
the prosthetic valve may be advanced over delivery lumens 27a and
27b, as shown. The prosthetic valve is placed at the native valve
and, subsequently, the grasping elements are retracted proximally
toward commissures 8 and 10, as shown in the transition from FIG.
5B to FIG. 5C. For some applications, the grasping elements are
coupled to valve 80 via coupling tubes 107a and 107b, the coupling
tubes being coupled to the sides of the valve, as shown. The
grasping elements are closed such that the native commissures are
grasped and sealed by the grasping elements, as shown in FIG. 5D.
Typically, the grasping elements define two surfaces that are
hingedly coupled to each other. For example, the grasping elements
may include forceps, as shown. The grasping elements are closed by
closing the surfaces about the hinge, with respect to one
another.
Typically, grasping elements 106a and 106b facilitate sealing of
native commissures 8 and 10, thereby reducing retrograde blood flow
via the commissures, relative to retrograde blood flow in the
absence of the grasping elements. Further typically, the sealing of
the native commissures facilitates anchoring of the prosthetic
valve to native valve 5.
Although not shown, for some applications, prosthetic valve support
40 is used in addition to grasping elements 106a and 106b, in order
to anchor prosthetic valve 80 to native valve 5. For some
applications, the grasping elements are used to anchor and/or
provide sealing for prosthetic valve support 40 (instead of, or in
addition to, being used to anchor prosthetic valve 80, as shown).
For such applications, generally similar techniques are used to
those described with respect to the use of the grasping elements
for anchoring the prosthetic valve, mutatis mutandis.
Reference is now made to FIGS. 6A-B, which are schematic
illustrations of prosthetic valve 80, the prosthetic valve
comprising a sealing material 110 on an outer surface of the valve,
in accordance with some applications of the present invention. For
some applications, prosthetic valve 80 is used in conjunction with
prosthetic valve support 40, as described hereinabove. The
techniques for implanting prosthetic valve 80 as shown in FIGS.
6A-B are generally similar to those described hereinabove.
Typically, sealing material 110 seals the interface between the
prosthetic valve and native valve 5. The sealing material reduces
retrograde blood flow from ventricle 6 into atrium 4, relative to
retrograde blood flow in the absence of the sealing material.
Typically, the sealing material is composed of latex, dacron,
and/or any other suitable biocompatible material. The sealing
material is typically placed around at least a portion of
expandable frame 79 of the prosthetic valve so as to form a webbing
between struts of the expandable frame.
Reference is now made to FIGS. 7A-F, which are schematic
illustrations of a guide wire delivery system, in accordance with
some applications of the present invention. As described
hereinabove (e.g., with reference to FIGS. 2C-F), for some
applications, guide members 21a and 21b, function as valve support
guide members, by support 40 being slid along guide members 21a and
21b. For some applications, only one guide member 21 is looped
through commissures 8 and 10 in a manner in which the guide member
defines a looped portion between commissures 8 and 10 (i.e., a
portion of the guide member that is disposed in a ventricle 6 of
heart 2), and first and second free ends, which are disposed and
accessible at a site outside the body of the patient. For such
applications, the guide member defines portions 21a and 21b.
For some applications, an anchor 302 is advanced toward the
vicinity of apex 304 of heart 2, via sheath 25, and is anchored to
the vicinity of the apex, as shown in FIG. 7A. A guidewire 306
extends proximally from anchor. Guide member 21 passes through a
guide member tube 320, the guide member tube being coupled to
guidewire 306. Guide member 21 is pushed distally. Guide member
tube 320 is unable to advance distally over guidewire 306, due to
the coupling of the guide member tube to the guidewire. Therefore,
the pushing of guide member 21 distally, causes portions 21a and
21b to spread apart from one another and to be pushed against
commissures 8 and 10 of native valve 5. Portions 21a and 21b are
then used to guide valve support 40 to the commissures, as shown in
FIGS. 7B-C, using generally similar techniques to those described
hereinabove, except for the differences described hereinbelow.
As shown in FIG. 7B, valve support 40 is slid over guide member
portions 21a and 21b, by pushing elements 52a and 52b. Since the
guide member portions are positioned at commissures 8 and 10, the
guide member portions guide the distal ends of pushing elements 52a
and 52b, such that the pushing elements push the valve support
against the commissures, as shown in FIG. 7C.
Subsequent to the placement of valve support 40 at the native
valve, prosthetic atrioventricular valve 80 is coupled to valve
support 40. For some applications, pushing elements 52a and 52b
continue to push the valve support against the native valve, during
the coupling of the prosthetic valve to the valve support. As
described hereinabove, overtube 70 is advanced into ventricle 6, as
shown in FIG. 7D. FIG. 7E shows prosthetic valve having been
partially deployed in the ventricle. Following the partial
deployment of valve 80 in ventricle 6, overtube 70 is pulled
proximally to pull valve 80 proximally such that cylindrical
element 42 and/or annular element 44 of valve support 40 surrounds
a proximal portion of prosthetic valve 80. Valve 80 has a tendency
to expand such that valve 80 is held in place with respect to valve
support 40 responsively to radial forces acted upon valve support
40 by prosthetic valve 80. During the pulling back of overtube 70,
pushing elements 52a and 52b push valve support 40 against the
valve, thereby providing a counter force against which overtube 70
is pulled back. For some applications, the pushing of the valve
support against the commissures is such that it is not necessary to
use anchors for anchoring the valve support to the native valve
during the coupling of the prosthetic valve to the valve support.
Alternatively, in addition to the pushing elements providing a
counter force against which the prosthetic valve is pulled, anchors
are used to anchor the valve support to the native valve during the
coupling of the prosthetic valve to the valve support.
As described hereinabove, valve 80 comprises a plurality of distal
protrusions 84. When valve 80 is pulled proximally, as described
hereinabove, protrusions 84 ensnare and engage the native leaflets
of the atrioventricular valve. By the ensnaring of the native
leaflets, protrusions 84 sandwich the native valve between
protrusions 84 and prosthetic valve support 40. Such ensnaring
helps further anchor prosthetic valve 80 to the native
atrioventricular valve.
For some applications, as described hereinabove, protrusions 84 are
such as to (a) prevent proximal migration of the valve into the
patient's atrium, while (b) allowing movement of the native
leaflets with respect to the frame of the prosthetic valve. For
example, the protrusions may have the aforementioned
functionalities by having lengths of less than 5 mm and/or by a
total width of each set of protrusions corresponding to respective
leaflets of the native valve being less than 5 mm. For example, the
valve may include a single protrusion corresponding to each leaflet
of the native valve, the width of each of the single protrusions
being less than 1 mm. Thus, the valve may be stopped from
proximally migrating into the atrium, by the protrusions preventing
the distal end of the valve from migrating further proximally than
edges of native leaflets of the valve. Furthermore, the protrusions
may allow movement of the native leaflets with respect to the frame
of the prosthetic valve by not generally squeezing the native
leaflets between the protrusions and the frame of the valve. For
some applications, by allowing movement of the native leaflets with
respect to the frame of the prosthetic valve, sealing of the native
leaflets against the outer surface of the frame of the prosthetic
valve is facilitated, in accordance with the techniques described
hereinbelow with reference to FIG. 10.
Subsequent to the placement of the prosthetic valve at the native
valve, sheath 25, overtube 70, pushing elements 52a and 52b, guide
member 21, anchor 302, and guidewire 306 are removed from the
patient's body, as shown in FIG. 7F, which shows the prosthetic
valve in its deployed state. For some applications, in order to
remove guide member 21 from the patient's body, guide member
portions 21a and 21b are decoupled from guide member tube 320. For
example, the guide member portions may be coupled to the guide
member tube via threading, the guide member portions being
decoupled from the guide member tube by unscrewing the guide member
portions from the guide member tube.
Reference is now made to FIGS. 8A-C which are schematic
illustrations of a system 120 comprising an invertible valve
support 140, in accordance with some applications of the present
invention. Invertible valve support 140 is identical to valve
support 40 described herein, with the exception that the
cylindrical element of valve support 140 is invertible, as is
described hereinbelow. Additionally, the method of advancing toward
and implanting valve support 140 at annulus 11 is identical to the
methods of advancing toward and implanting valve support 40 at
annulus 11, as described hereinabove.
Valve support 140 comprises an annular element 144 (that is
identical to annular element 44 described hereinabove) and a
cylindrical element 142. Cylindrical element 142 has a first end
150, a second end 152, and a cylindrical body 153 disposed between
first and second ends 150 and 152. Cylindrical element 142 is
attached to annular element 144 at first end 150 of cylindrical
element 142.
During and following implantation of support 140 at annulus 11, as
shown in FIG. 8A, cylindrical element 142 is disposed above annular
element 144 in a manner in which second end 152 and cylindrical
body 153 are disposed above annular element 144 and within atrium
4. One or more elongate guide members 146a and 146b are reversibly
coupled to cylindrical element 142 in a vicinity of second end 152.
Elongate guide members 146a and 146b facilitate (a) advancement of
prosthetic valve 80 therealong and toward valve support 140, and
(b) inversion of cylindrical element 142 toward ventricle 6 when at
least a portion of valve 80 is deployed within ventricle 6 (as
shown in FIG. 8B).
The configuration of valve support 140 as shown in FIG. 8A (i.e.,
the configuration in which cylindrical element 142 is disposed
within atrium 4) eliminates the obstruction of native valve 5 and
of leaflets 12 and 14 by any portion of valve support 140. In this
manner, valve support 140 may be implanted at valve 5 while valve 5
resumes its native function and leaflets 12 and 14 resume their
natural function (as shown by the phantom drawing of leaflets 12
and 14 in FIG. 8A which indicates their movement). This
atrially-inverted configuration of valve support 140 reduces and
even eliminates the amount of time the patient is under
cardiopulmonary bypass. Only once prosthetic valve 80 is delivered
and coupled to valve support 140 and cylindrical element 142 is
thereby ventricularly-inverted, native leaflets 12 and 14 are
pushed aside (FIG. 8B).
FIG. 8B shows the inversion of cylindrical element 142 by the
partial positioning and deployment of prosthetic valve 80 within
ventricle 6. Elongate guide members 146a and 146b are reversibly
coupled to prosthetic valve 80 and extend within overtube 70.
Following the full deployment of valve 80 and the coupling of valve
80 to valve support 140, elongate guide members 146a and 146b are
decoupled from prosthetic valve 80 and from cylindrical element
142. For example, a cutting tool may be used to decouple elongate
members 146a and 146b from the valve support 140. Alternatively,
elongate members 146a and 146b may be looped through the
cylindrical element 142, such that both ends of each elongate
member 146a and 146b remain outside of the patient's body. The
operating physician decouples elongate members 146a and 146b from
valve support 140 by releasing one end of each of elongate members
146a and 146b and pulling on the other end, until elongate members
146a and 146b are drawn from valve support 140 and removed from
within the body of the patient.
FIG. 8C shows prosthetic valve 80 coupled to valve support 140.
Valve 80 is identical to the valve described hereinabove.
Reference is now made to FIGS. 9A-E, which are schematic
illustrations of the advancement of an invertible prosthetic valve
support 300 toward a native atrioventricular valve of a patient,
and inversion of the valve support, in accordance with some
applications of the present invention. Prosthetic valve support 300
is used to anchor prosthetic valve 80 to native valve 5 in a
generally similar manner to that described with reference to
prosthetic valve support 40.
During a typical procedure, anchor 302 is advanced toward the
vicinity of apex 304 of heart 2, via sheath 25, and is anchored to
the vicinity of the apex, as shown in FIG. 8A. A guidewire 306
extends proximally from anchor. A distal tensioning element 308
(e.g., a plunger) is advanced over guidewire 306 into ventricle 6,
and prosthetic valve support 300 is advanced out of the distal end
of sheath 25, as shown in FIG. 9B. A first end 310 of prosthetic
valve support 300 (which at this stage is the distal end of the
prosthetic valve support), comprises barbs 314 (shown in FIG. 9B),
or other anchoring elements for anchoring the first end of the
prosthetic valve support to tissue of native valve 5. Prosthetic
valve support 300 is pushed distally such that the barbs are pushed
into the native valve tissue, thereby anchoring the first end of
the prosthetic valve support to the native valve, as shown in FIG.
9C. A plurality of wires 309 pass from distal tensioning element
308 to a proximal tensioning element 311 (shown in FIG. 9D), via a
second end 312 of valve support 300 (which at this stage is the
proximal end of the prosthetic valve support). For some
applications, a sealing element 316 is disposed circumferentially
around a surface of the invertible prosthetic valve support that is
initially an inner surface of the invertible prosthetic valve
support (a shown in FIGS. 8A-D). For example, the sealing material
may be latex, dacron, or another suitable biocompatible sealing
material.
Subsequent to the anchoring of first end 310 of prosthetic valve
support 300 to native valve tissue (as shown in FIG. 9C), distal
tensioning element 308 is further advanced distally into ventricle
6, and proximal tensioning element 311 is advanced toward the
ventricle. As shown in the transition from FIG. 9D-F, as the
proximal tensioning element passes through the valve support, wires
309 cause valve support 300 to invert, by pulling second end 312 of
the valve support through first end 310 of the valve support.
Subsequent to the inversion of the valve support, sealing material
316 is disposed circumferentially around the outside of the valve
support, thereby providing a seal at the interface between valve
support 300 and native valve 5.
Reference is now made to FIGS. 9G-H, which are schematic
illustrations of the deployment of prosthetic valve 80 and the
coupling of the prosthetic valve to invertible valve support 300,
in accordance with some applications of the present invention.
The deployment of prosthetic valve 80 is generally similar to the
techniques described hereinabove with reference to FIGS. 2H-J. The
valve is partially deployed in ventricle 6, via overtube 70.
Following the partial deployment of valve 80 in ventricle 6,
overtube 70 is pulled proximally (as shown in FIG. 8G) to pull
valve 80 proximally such that valve support 300 surrounds a
proximal portion of prosthetic valve 80, as shown in FIG. 8H. Valve
80 has a tendency to expand such that valve 80 is held in place
with respect to valve support 300 responsively to radial forces
acted upon valve support 300 by prosthetic valve 80.
As described hereinabove, for some applications, valve 80 comprises
a plurality of distal protrusions 84. When valve 80 is pulled
proximally, protrusions 84 ensnare and engage the native leaflets
of the atrioventricular valve. By the ensnaring of the native
leaflets, protrusions 84 sandwich the native valve between
protrusions 84 and prosthetic valve support 300. Such ensnaring
helps further anchor prosthetic valve 80 to the native
atrioventricular valve.
For some applications, as described hereinabove, protrusions 84 are
such as to (a) prevent proximal migration of the valve into the
patient's atrium, while (b) allowing movement of the native
leaflets with respect to the frame of the prosthetic valve. For
example, the protrusions may have the aforementioned
functionalities by having lengths of less than 5 mm, and/or by a
total width of each set of protrusions corresponding to respective
leaflets of the native valve being less than 5 mm. For example, the
valve may include a single protrusion corresponding to each leaflet
of the native valve, the width of each of the single protrusions
being less than 1 mm. Thus, the valve may be stopped from
proximally migrating into the atrium, by the protrusions preventing
the distal end of the valve from migrating further proximally than
edges of native leaflets of the valve. Furthermore, the protrusions
may allow movement of the native leaflets with respect to the frame
of the prosthetic valve by not generally squeezing the native
leaflets between the protrusions and the frame of the valve. For
some applications, by allowing movement of the native leaflets with
respect to the frame of the prosthetic valve, sealing of the native
leaflets against the outer surface of the frame of the prosthetic
valve is facilitated, in accordance with the techniques described
hereinbelow with reference to FIG. 10.
Additionally, as shown in FIG. 9H, and as described hereinabove,
valve 80 comprises one or more coupling elements 81 (for example, a
plurality of coupling elements, as shown) at the proximal end of
valve 80. Overtube 70, which facilitates the advancement of
prosthetic valve 80, is reversibly coupled to valve 80, via
coupling elements 81.
Subsequent to the coupling of valve 80 to valve support 300,
overtube 70, distal and proximal tensioning elements 308 and 311,
and wires 309 are removed from the patient's body, via sheath 25.
Typically, wires 309 are cut, in order to facilitate the removal of
the wires from the patient's body. Guidewire 306 and anchor 302 are
removed from the patient's body by detaching the anchor from apex
304, and withdrawing the anchor and the guidewire, via sheath
25.
Reference is now made to FIG. 10, which is a schematic illustration
of prosthetic valve 80, for placing inside atrioventricular valve 5
of the patient, in accordance with some applications of the present
invention. The expandable frame 79 of the prosthetic valve has a
diameter d, and a corresponding cross-sectional area. Native
annulus 11, which is typically saddle-shaped, defines an area A, as
shown. For some applications, area A, which is defined by the
native annulus is measured, e.g., using a measuring ring. A
prosthetic valve is chosen to be placed in the annulus, the
cross-sectional area of the prosthetic valve being less than 90%
(e.g., less than 80%, or less than 60%) of area A. For some
applications, diameter d of the prosthetic valve is less than 25
mm, e.g., less than 20 mm, and/or more than 15 mm, e.g., 15-25 mm.
For some applications, placing a prosthetic valve inside the native
valve with the dimensions of the native valve annulus and the
prosthetic valve as described, facilitates sealing of the
prosthetic valve with respect to the native valve, by the native
valve leaflets closing around the outer surface of the prosthetic
valve.
For some applications, a prosthetic valve support 40 that includes
annular element 44 (e.g., as shown in FIGS. 14A-C) is chosen to be
placed at the annulus, the annular element defining an inner
cross-sectional area that is less than 90% (e.g., less than 80%, or
less than 60%) of area A. Prosthetic valve 80 is deployed at the
native valve by coupling the prosthetic valve to the prosthetic
valve support at the location, responsively to radial forces acted
upon the valve support by the expandable frame, by facilitating
expansion of the expandable frame, as described herein. The
cross-sectional area defined by the expandable frame of the
prosthetic valve, upon expansion of the expandable frame, is
limited by the cross-sectional area defined by the annular element
of the prosthetic valve support to less than 90% (e.g., less than
80%, or less than 60%) of area A. For some applications, placing a
prosthetic valve support at the annulus with the dimensions of the
native valve annulus and valve support 40, as described,
facilitates sealing of the prosthetic valve with respect to the
native valve, by the native valve leaflets closing around the outer
surface of the prosthetic valve.
Typically, placing a prosthetic valve inside the native valve with
the dimensions of the native valve annulus, the prosthetic valve
80, and/or valve support 40 as described in the above paragraphs,
facilitates sealing of the prosthetic valve with respect to the
native valve. For some applications, the sealing is facilitated by
the native leaflets being pushed against, and closing against, the
outer surface of the frame of the valve during systole, in a
similar manner to the manner in which native valve leaflets coapt
during systole, in a healthy mitral valve. Typically, as the
diameter of the prosthetic valve is increased, the length of the
native leaflets that is pushed against the outer surface of the
valve during systole is increased, thereby enhancing the sealing of
the native leaflets with respect to the frame of the prosthetic
valve. However, beyond a given diameter, as the diameter of the
prosthetic valve is increased, the native valve leaflets are pushed
apart at the commissures, thereby causing retrograde leakage of
blood through the commissures. Therefore, in accordance with some
applications of the present invention, prosthetic valve 80, and/or
valve support 40 are chosen such that the cross-sectional area of
the prosthetic valve when expanded inside the valve support is less
than 90% (e.g., less than 80%, or less than 60%) of area A. Thus
the valve support facilitates sealing of the prosthetic valve with
respect to the native valve, by the native valve leaflets closing
around the outer surface of the prosthetic valve, while not causing
retrograde leakage of blood through the commissures.
For some applications, in order to facilitate the sealing of the
native valve around the outer surface of the prosthetic valve, a
material is placed on the outer surface of the prosthetic valve in
order to provide a sealing interface between the prosthetic valve
and the native valve. For example, a smooth material that prevents
tissue growth (e.g., polytetrafluoroethylene (PTFE), and/or
pericardium) may be placed on the outer surface of the prosthetic
valve. Alternatively or additionally, a material that facilitates
tissue growth (such as dacron) may be placed on the outer surface
of the prosthetic valve, in order to (a) act as a sealing interface
between the native valve and the prosthetic valve, and (b)
facilitate tissue growth around the prosthetic valve to facilitate
anchoring and/or sealing of the prosthetic valve.
Reference is now made to FIGS. 11A-D, which are schematic
illustrations of prosthetic valve 80, in accordance with some
applications of the present invention. For some applications,
protrusions 84 are disposed on the valve on portions 400 of the
valve that are placed adjacent to the anterior and posterior
leaflets of the native valve, and the valve does not includes
protrusions on portions 402 of the valve that are placed adjacent
to the commissures of the native valve.
FIGS. 11B-D show bottom views (i.e., views of the distal ends) of
respective configurations of prosthetic valve 80 and protrusions
84. The protrusions converge from the proximal ends 404 of the
protrusion to the distal ends 406 of the protrusions. The
protrusions are configured such as to ensnare chordae tendineae,
and to pull the chordae tendineae toward each other when the
prosthetic valve is pulled proximally, due to the convergence of
the snares with respect to each other. FIG. 11D shows the
prosthetic valve deployed at native valve 5. As shown, the
protrusions ensnare chordae tendineae 102 of the patient. The
protrusions facilitate sealing and anchoring of the prosthetic
valve with respect to the native valve by pulling the chordae
tendinae toward each other, as described. As described hereinabove,
for some applications the prosthetic valve does not define
protrusions 84 on portions 402 that are placed next to the native
commissures, e.g., commissure 8, shown in FIG. 11D.
For some applications, as described hereinabove, protrusions 84 are
such as to (a) prevent proximal migration of the valve into the
patient's atrium, while (b) allowing movement of the native
leaflets with respect to the frame of the prosthetic valve. For
example, the protrusions may have the aforementioned
functionalities by having lengths of less than 5 mm, and/or by a
total width of each set of protrusions corresponding to respective
leaflets of the native valve being less than 5 mm. For example, the
valve may include a single protrusion corresponding to each leaflet
of the native valve, the width of each of the single protrusions
being less than 1 mm. Thus, the valve may be stopped from
proximally migrating into the atrium, by the protrusions preventing
the distal end of the valve from migrating further proximally than
edges of native leaflets of the valve. Furthermore, the protrusions
may allow movement of the native leaflets with respect to the frame
of the prosthetic valve by not generally squeezing the native
leaflets between the protrusions and the frame of the valve. For
some applications, by allowing movement of the native leaflets with
respect to the frame of the prosthetic valve, sealing of the native
leaflets against the outer surface of the frame of the prosthetic
valve is facilitated, in accordance with the techniques described
hereinabove with reference to FIG. 10.
For some applications, a first set of protrusions 84 from the
distal end of prosthetic valve 80 are disposed within a first
circumferential arc with respect to a longitudinal axis of the
prosthetic valve, on a first side of the distal end of the
prosthetic valve, the first side of the distal end being configured
to be placed adjacent to the anterior leaflet of the native valve.
A second set of protrusions are disposed within a second
circumferential arc with respect to a longitudinal axis of the
prosthetic valve, on a second side of the distal end of the
prosthetic valve, the second side of the distal end being
configured to be placed adjacent to the posterior leaflet of the
native valve.
The first and second sets of protrusions are disposed so as to
provide first and second gaps therebetween at the distal end of the
prosthetic valve. Typically, at least one of the gaps between the
two sets of protrusions has a circumferential arc of at least 20
degrees (e.g., at least 60 degrees, or at least 100 degrees),
and/or less than 180 degrees (e.g., less than 140 degrees), e.g.,
60-180 degrees, or 100-140 degrees. Further typically, one or both
of the first and second circumferential arcs defines an angle of at
least 25 degrees (e.g., at least 45 degrees), and/or less than 90
degrees (e.g., less than 75 degrees), e.g., 25-90 degrees, or 45-75
degrees.
Valve guide members (e.g., guide members 21a and 21b, and/or
delivery lumen 27a and 27b, as described hereinabove) are delivered
to commissures of the native valve, and guide the valve such that
the first and second circumferential arc are aligned with
respective leaflets of the native valve and such that the first and
second gaps are aligned with respective commissures of the native
valve.
Reference is now made to FIGS. 12A-C, which are schematic
illustrations of prosthetic valve 80, the valve defining distal
protrusions 84 that are disposed sinusoidally around the
circumference of the valve, in accordance with some applications of
the present invention. For some applications the protrusions are
shaped sinusoidally, in order to conform with the saddle-shape of
native valve annulus 11, thereby facilitating the sandwiching of
the native valve leaflets between the protrusions and valve support
40. As shown, the peaks of the sinusoid that is defined by the
protrusions is disposed on portions 402 that are placed next to the
native commissures and the troughs of the sinusoid is placed on
portions of the valve that are placed in the vicinity of the
centers of the anterior and posterior leaflets of the native valve.
As shown in FIG. 12C, for some applications the distal end of the
prosthetic valve defines a sinusoidal shape.
Reference is now made to FIGS. 13A-E, which are schematic
illustrations of respective configurations of expandable frame 79
of prosthetic valve 80, in accordance with some applications of the
present invention. As described hereinabove, for some applications,
valve 80 defines distal protrusions 84 that are configured to
facilitate sandwiching of the native valve leaflets between the
protrusions and valve support 40. For some applications, tips of
the distal protrusions are shaped so as to prevent the tips from
piercing, and/or otherwise damaging, tissue of the native leaflets.
For example, the tips of the protrusions may be curved, as shown in
FIG. 13A. Or, the distal tips of the protrusions may be shaped as
balls, as shown in FIG. 13, and/or a different rounded shape. For
some applications, the distal tip of each of the protrusions is
joined to the distal tip of an adjacent protrusion by an arch 410,
as shown in FIGS. 13C and 13D.
For some applications, the protrusions are configured to be
distally-facing during the insertion of prosthetic valve 80 into
the subject's left ventricle. For example, the valve may be
inserted through overtube 70 (shown in FIG. 7E, for example). The
valve is crimped during the insertion of the valve through the
overtube, and the protrusions are constrained in their
distally-facing configurations by the overtube. The protrusions are
pre-shaped such that in the resting state of the protrusions, the
protrusions assume proximally-facing configurations, as shown in
FIG. 13D, for example. Thus, upon emerging from overtube 70, the
protrusions assume proximally-facing configurations. For some
applications, when the protrusions assume the proximally-facing
configurations, the protrusions are disposed at an angle theta
(FIG. 13D) from expandable frame 79 of more than 40 degrees (e.g.,
more than 50 degrees), and/or less than 80 degrees (e.g., less than
70 degrees).
Typically, protrusions 84 are coupled to frame 79 of valve 80 at
joints 412. For some applications, joints 412 are thinner than
portions of the protrusions and of the frame surrounding the
joints, as shown in FIG. 13D. For some applications, the thinness
of the joints with respect to the surrounding portions facilitates
the crimping of the protrusions into distally-facing configuration
during the insertion of the valve into the heart.
For some applications, barbs 416 extend from a proximal portion of
expandable frame 79 of valve 80, as shown in FIG. 13E. For example,
the barbs may be configured to anchor the prosthetic valve to the
native valve by piercing tissue of the native valve. Alternatively
or additionally, the barbs may be configured to anchor the
prosthetic valve to the valve support 40, by becoming coupled to
portions of the valve support. For some applications the barbs
protrude from the top-central corner of respective cells of
expandable frame 79. Typically, when the prosthetic valve is
crimped, the barbs fit within gaps of respective cells of the
expandable frame, and do not substantially increase the crimping
profile of the prosthetic valve, relative to a generally similar
prosthetic valve that does not include barbs.
For some applications, the barbs are not generally used for
coupling prosthetic valve support 80 to valve support 40. Rather,
the prosthetic valve is coupled to the valve support by virtue of
radial expansion of the prosthetic valve against annular element 44
of the valve support. Barbs 416 are used to prevent prosthetic
valve from migrating distally into the patient's left ventricle,
and/or to prevent valve support 40 from migrating proximally into
the subject's left atrium.
For some applications (not shown), barbs protrude from coupling
elements 81 of prosthetic valve 80, the barbs being generally
similar in shape and function to that described with reference to
barbs 416. For some applications (not shown), radially-inwardly
facing barbs 45 protrude from annular element 44 of valve support
40, as shown in FIG. 14D. As described with reference to barbs 416,
the barbs that protrude from annular element 44 may facilitate
coupling of the prosthetic valve to the valve support.
Alternatively or additionally, the barbs that protrude from annular
element 44 are used to prevent prosthetic valve from migrating
distally into the patient's left ventricle, and/or to prevent valve
support 40 from migrating proximally into the subject's left
atrium.
For some applications, a proximal end of expandable frame 79 of
prosthetic valve 80 defines a larger cross-section area than more
distal portions of the expandable frame. For example, the
expandable frame may have a frustoconical shape, the walls of the
expandable frame diverging from a distal end of the frame to a
proximal end of the frame. Alternatively, the expandable frame may
have a trumpet shape (i.e., the frame may be generally tubular,
with a dilated proximal end). For some applications, the larger
cross-sectional area of the proximal end of the frame prevents the
prosthetic valve from migrating distally into the patient's left
ventricle, and/or prevents valve support 40 from migrating
proximally into the subject's left atrium.
Reference is now made to FIGS. 14A-D, which are schematic
illustrations of respective configurations of prosthetic valve
support 40, in accordance with some applications of the present
invention. As described hereinabove, for some applications, the
valve support comprises a collapsible skirt having a proximal
annular element 44 and a distal cylindrical element 42 (e.g., as
shown in FIG. 2D). Alternatively, the valve support does not
include a distal cylindrical element. For example, the valve
support may only include annular element 44. As described
hereinabove, annular element 44 is configured to be placed around
native annulus 11 of the native valve, and to extend at least
partially into atrium 4 such that annular element 44 rests against
the native annulus. Annular element 44 is typically too large to
pass through the annulus, and may, for example, have an outer
diameter of between 30 and 60 mm.
FIGS. 14A-D show annular element 44 of valve support 40 in
respective configurations, in accordance with some applications of
the present invention. For some applications, the annular element
is D-shaped, as shown in FIG. 14A. Alternatively or additionally,
the annular element has a generally round shape, as shown in FIGS.
14B-C. For some applications the annular element is asymmetrical.
For example, FIG. 14B shows a generally rounded annular element
that is wider on a first side 420 of the element than on a second
side 422 of the element. Typically, the wider side of the annular
element is placed on the anterior side of the native annulus. In
accordance with some applications, the annular element is
symmetrical, asymmetrical, oval, round, defines a hole that is
centered with respect to the annular element, and/or defines a hole
that is off-center with respect to the annular element. For some
applications, the stiffness of the annular element varies around
the circumference of the annular element.
For some applications, annular element 44 is asymmetrical, as shown
in FIG. 14B. Typically, the asymmetry of the annular element is
such that the center of the hole defined by the annular element is
disposed asymmetrically (i.e., off-center) with respect to the
center of the annular element, as defined by the outer perimeter of
the annular element. For some applications, the asymmetric
disposition of the center of the hole defined by the annular
element is such that when the prosthetic valve is placed inside the
annular element, the longitudinal axis of the prosthetic valve is
disposed asymmetrically (i.e., off-center) with respect to the
center of the annular element, as defined by the outer perimeter of
the annular element. Typically, the annular element is shaped such
that, when the annular element is placed on the patient's mitral
annulus, and the prosthetic valve is expanded inside the annular
element, the longitudinal axis of the prosthetic valve is disposed
in the vicinity of the location at which the patient's native
leaflets coapt (this location being off-center with respect to the
patient's native mitral annulus).
For some applications (not shown), radially-inwardly facing barbs
45 protrude from annular element 44 of valve support 40, as shown
in FIG. 14D. As described with reference to barbs 416 shown
protruding from prosthetic valve 80 in FIG. 13E, the barbs that
protrude from annular element 44 may facilitate coupling of the
prosthetic valve to the valve support. Alternatively or
additionally, the barbs that protrude from annular element 44 are
used to prevent prosthetic valve from migrating distally into the
patient's left ventricle, and/or to prevent valve support 40 from
migrating proximally into the subject's left atrium. For some
applications, some or all of barbs 102 are curved. Typically, the
curved barbs curve away from the plane of annular element 40, such
that, when implanted, barbs 102 point into the patient's
atrium.
Typically, the annular element includes frame 48, the frame being
covered at least in part with covering 49, e.g., fabric. Typically,
the upper surface of annular element 44 is covered with fabric, for
example, in order to provide a generally smooth surface for coming
into contact with the patient's blood flow. Further typically, the
lower surface of the annular element (i.e., the side of the annular
element that is placed in contact with the native annulus) is not
covered with fabric, for example, in order to reduce a crimped
volume (or cross-sectional area) of the annular element, relative
to the volume of the annular element if the lower surface of the
annular element were covered in fabric. Typically, a thickness of
the fabric layer is less than 0.2 mm, e.g., less than 0.1 mm, or
less than 0.05 mm.
For some applications, the side of the annular element that is
placed in contact with the native annulus is covered with the
fabric, the fabric being configured to facilitate coupling of the
annular element to the native annulus, by facilitating fibrosis at
the interface between the annular element and the native annulus.
For some applications, the upper surface of the annular element is
not covered with fabric. For example, the upper surface may not be
covered in fabric in order to reduce a crimped volume (or
cross-sectional area) of the annular element, relative to the
volume of the annular element if the upper surface of the annular
element were covered in fabric.
For some applications, annular element 44 is not covered with
fabric, and/or is not configured to form a seal against frame 79 of
prosthetic valve 80. For some applications, the annular element is
configured to allow leakage of blood between the annular element
and frame 79 of prosthetic valve 80. For example, the annular
element may be configured to allow leakage of blood through the
interface between the annular element and the frame of the
prosthetic valve, in order to accommodate a flow of blood between
the patient's atrium and the patient's ventricle that is greater
than can be accommodated by blood flowing through the leaflets of
the prosthetic valve.
Reference is now made to FIGS. 15A-E, which are schematic
illustrations of respective steps of a procedure for deploying a
prosthetic valve, in accordance with some applications of the
present invention. As described hereinabove and hereinbelow (for
example, with reference to FIGS. 2A-K, 7A-F, 8A-C, 9A-H, and
16A-G), for some procedures, valve support 40 is placed on the
valve annulus and, subsequently, prosthetic valve 80 is inserted
into the subject's left ventricle through the valve support.
Alternatively, any of the procedures described herein (for example,
procedures described with reference to FIGS. 2A-K, 7A-F, 8A-C,
9A-H, and 16A-G) may be performed by first placing the prosthetic
valve inside the subject's left ventricle, and, subsequently,
deploying the valve support at the annulus. For example, FIGS.
15A-E show a procedure in which the prosthetic valve is placed
inside the subject's left ventricle, and, subsequently, the valve
support is deployed at the annulus.
As shown in FIG. 15A, for some applications, prosthetic valve 80 is
placed in the subject's ventricle, before prosthetic valve support
40 is placed at the native valve. The prosthetic valve is typically
placed in the left ventricle in an undeployed state, via overtube
70. Subsequently, the valve support is placed at the native valve
using pushing elements, as shown in FIG. 15B. For some
applications, three pushing elements 52a, 52b, and 52c are used to
push the valve support against the native valve, as shown in FIG.
15B.
Subsequent to the placement of valve support 40 at the native
valve, prosthetic valve 80 is coupled to valve support 40. For some
applications, pushing elements 52a, 52b, and 52c continue to push
the valve support against the native valve, during the coupling of
the prosthetic valve to the valve support. FIG. 15C shows
prosthetic valve having been partially deployed in the
ventricle.
Following the partial deployment of valve 80 in ventricle 6,
overtube 70 is pulled proximally to pull valve 80 proximally such
that annular element 44 of valve support 40 surrounds a proximal
portion of prosthetic valve 80, as shown in FIG. 15D. Valve 80 has
a tendency to expand such that valve 80 is held in place with
respect to valve support 40 responsively to radial forces acted
upon valve support 40 by prosthetic valve 80. During the pulling
back of overtube 70, pushing elements 52a, 52b, and 52c push valve
support 40 against the valve, thereby providing a counter force
against which overtube 70 is pulled back. For some applications,
the pushing of the valve support against the commissures is such
that it is not necessary to use anchors for anchoring the valve
support to the native valve during the coupling of the prosthetic
valve to the valve support. Alternatively, in addition to the
pushing elements providing a counter force against which the
prosthetic valve is pulled, anchors are used to anchor the valve
support to the native valve during the coupling of the prosthetic
valve to the valve support.
As described hereinabove, valve 80 comprises a plurality of distal
protrusions 84. When valve 80 is pulled proximally, as described
hereinabove, protrusions 84 ensnare and engage the native leaflets
of the atrioventricular valve. By the ensnaring of the native
leaflets, protrusions 84 sandwich the native valve between
protrusions 84 and prosthetic valve support 40. Such ensnaring
helps further anchor prosthetic valve 80 to the native
atrioventricular valve.
It is noted with reference to FIG. 15D that, typically, annular
element 44 of prosthetic valve support 40 defines an inner
cross-sectional area thereof. As described hereinabove, prosthetic
valve 80 includes expandable frame 79, and prosthetic leaflets 82.
The expandable frame of the prosthetic valve is configured such
that when the frame is in a non-constrained state thereof, the
cross-sectional area of the frame, along at least a given portion L
(shown in FIG. 15D) of the length of the frame, is greater than the
inner cross-sectional area defined by the annular element of the
prosthetic valve support. Typically, during a valve-deployment
procedure, a location anywhere along portion L at which to couple
the expandable valve to the prosthetic valve support is selected.
In response thereto, the location along the portion of the
expandable frame is aligned with the annular element of the
prosthetic valve support. The expandable valve is then coupled to
the prosthetic valve support at the location, responsively to
radial forces acted upon the valve support by the expandable frame,
by facilitating expansion of the expandable frame, when the
location along the portion is aligned with the annular element of
the prosthetic valve support.
As described hereinabove, for some applications, expandable frame
79 of prosthetic valve 80 has a frustoconical shape. For some
applications, the prosthetic valve is coupled to valve support 40
responsively to radial forces acted upon the valve support by the
expandable frame, when a given location along portion L is aligned
with annular element 44 of the prosthetic valve support. For some
applications, the portion immediately proximal to the given
location along portion L has a greater cross-sectional area than
the frame at the given location, due to the frustoconical shape of
the expandable frame. Typically, the greater cross-sectional area
of the portion immediately proximal to the given location along
portion L relative to the cross-sectional area of the frame at the
given location, reduces distal migration of the prosthetic valve
toward the subject's left ventricle.
For some applications, the location along portion L at which to
couple prosthetic valve 80 to valve support 40 is selected, based
upon a distance D between protrusions 84 and annular element 44
that would result from coupling the prosthetic valve to the annular
element at that location. For example, the location along portion L
at which to couple prosthetic valve 80 to valve support 40 may be
selected, such that distance D is such as to anchor the prosthetic
valve to the patient's native valve by squeezing the patient's
native valve leaflets between the protrusions and the annular
element, and/or by ensnaring the patient's chordae tendinae between
the protrusions and the annular element. Alternatively or
additionally, the location along portion L at which to couple
prosthetic valve 80 to valve support 40 may be selected, such that
distance D is such that protrusions 84 (a) prevent proximal
migration of the valve into the patient's atrium, while (b)
allowing movement of the native leaflets with respect to the frame
of the prosthetic valve. Typically, the location along portion L is
selected such that distance D is such that the valve may be stopped
from proximally migrating into the atrium, by the protrusions
preventing the distal end of the valve from migrating further
proximally than edges of native leaflets of the valve, while the
protrusions allow movement of the native leaflets with respect to
the frame of the prosthetic valve by not generally squeezing the
native leaflets between the protrusions and the frame of the valve.
For some applications, by allowing movement of the native leaflets
with respect to the frame of the prosthetic valve sealing of the
native leaflets against the outer surface of the frame of the
prosthetic valve is facilitated, in accordance with the techniques
described hereinabove with reference to FIG. 10.
Subsequent to the placement of the prosthetic valve at the native
valve, overtube 70, and pushing elements 52a, 52b, and 52c are
removed from the patient's body, as shown in FIG. 15E, which shows
the prosthetic valve in its deployed state.
Reference is now made to FIGS. 16A-G, which are schematic
illustrations of respective steps of an alternative procedure for
deploying prosthetic valve 80, in accordance with some applications
of the present invention. As described hereinabove, with reference
to FIGS. 7A-F, for some applications, a looped guide member 21 is
looped through commissures 8 and 10 in a manner in which the guide
member defines a looped portion between commissures 8 and 10. For
some applications, the looped guide member has steering
functionality. The steering functionality of the looped guide
member is used to guide the guide member to the commissures, and/or
to guide other portions of the apparatus to the native valve and/or
to ventricle 6. The looped guide member is typically advanced
toward ventricle 6 over guidewire 306, e.g., as described
hereinabove with reference to FIG. 7A.
Typically, as shown in FIG. 16A, portions 21a and 21b of the looped
guide member are independently manipulable. The portions of the
looped guide member are manipulated (e.g., expanded and contracted)
so as to guide the looped guide member to the subject's native
valve, by pushing against inner surfaces of the subject's heart, as
shown in FIG. 16A.
FIG. 16B shows the looped guide member looped through commissures 8
and 10 of the subject's native valve. When the looped guide member
is disposed at the native valve, the guide member is used to guide
and to anchor valve support 40, as described hereinbelow.
As shown in FIG. 16C, for some applications, looped guide member 21
is coupled to valve support 40 via coupling wires 500 and coupling
mechanisms 502. For example, as shown, the coupling mechanism may
include an anchor. A suture 504, or a different looped element,
protrudes from the bottom surface of annular element 44 of valve
support 40 and is anchored by the anchor. Thus, when looped guide
member 21 is pushed distally into ventricle 6, the valve support is
pulled against the annulus of the native valve by coupling wires
500 pulling on the valve support.
Typically, coupling mechanisms 502, which are used to couple looped
guide member 21 to valve support 40 are detachable coupling
mechanisms. For example, as shown, the coupling mechanism may
include an anchor that defines an opening 506 through which suture
504 is inserted. The opening is closed by a closing member 508,
such as a rod, or a wire. In order to detach the guide member from
valve support, closing member 508 is opened (e.g., by being pulled
proximally) such that suture 504 is released through opening
506.
Subsequent to the placement of valve support 40 at the native
valve, prosthetic atrioventricular valve 80 is placed in ventricle
6, by advancing overtube 70 into the ventricle, as shown in FIG.
16D. FIG. 16E shows prosthetic valve having been partially deployed
in the ventricle. Following the partial deployment of valve 80 in
ventricle 6, overtube 70 is pulled proximally to pull valve 80
proximally such that annular element 44 of valve support 40
surrounds a proximal portion of prosthetic valve 80, as shown in
FIGS. 16E-F. Valve 80 has a tendency to expand such that valve 80
is held in place with respect to valve support 40 responsively to
radial forces acted upon valve support 40 by prosthetic valve
80.
During the pulling back of overtube 70, looped guide member 21 is
pushed distally, thereby pulling valve support 40 against the
native annulus and providing a counter force against which overtube
70 is pulled back. For some applications, pulling of the valve
support against the native annulus is such that it is not necessary
to use anchors for anchoring the valve support to the native valve
during the coupling of the prosthetic valve to the valve support.
Alternatively, in addition to the pulling of the valve support
against the native annulus providing a counter force against which
the prosthetic valve is pulled, anchors are used to anchor the
valve support to the native valve during the coupling of the
prosthetic valve to the valve.
FIG. 16G shows prosthetic valve 80 and valve support 40 coupled to
the native valve. At this stage, coupling mechanism 502 is
typically detached from the valve support. For example, as shown,
closing member 508 is pulled, such that opening 506 is opened, and
suture 504 is released through the opening. Subsequently, looped
guide member 21, and overtube 70 are removed from the subject's
body, as shown in FIG. 16H, which shows the prosthetic valve in its
deployed state.
As described with reference to FIGS. 16A-H, for some applications,
prosthetic valve 80 is coupled to a native valve, by (a) placing
valve support 40 on an atrial side of the native annulus, (b)
placing the prosthetic valve inside the ventricle, and then,
simultaneously, (c) pulling the prosthetic valve toward the atrium,
and pulling the valve support toward the ventricle.
Reference is now made to FIGS. 17A-C, which are schematic
illustrations of leaflets 82 of prosthetic valve 80, in accordance
with some applications of the present invention. FIG. 17A shows the
leaflets before the leaflets are sutured to expandable frame 79 of
the valve. As shown, in this state, the leaflets have a diameter
D1, and the leaflets are not fully closed. FIG. 17B shows the
leaflets when the leaflets have been sutured to expandable frame 79
of the prosthetic valve. The expandable frame constrains the
leaflets, such that the leaflets define a diameter D2, which is
smaller than diameter D1, thereby closing the leaflets. FIG. 17C
shows the leaflets subsequent to the deployment of valve 80 inside
valve support 40, the valve support constraining the expansion of
the prosthetic valve. Due to the valve support constraining the
prosthetic valve, the valve leaflets are constrained so as define a
diameter D3, which is smaller than diameter D2.
Typically, valve leaflets 82 are selected to be used in prosthetic
valve 80, the leaflets being sized such that both at diameter D2
(when the leaflets are constrained by expandable frame 79 but are
not constrained by valve support 40) and at diameter D3 (when the
leaflets are constrained by both expandable frame 79 and valve
support 40), the valve leaflets fully coapt.
Reference is now made to FIGS. 18A-B which are schematic
illustrations of a system 220 comprising a valve support 240
comprising an annular element 244 and a cylindrical element 242 and
one or more (e.g., a plurality, as shown, of) tissue anchors 230,
in accordance with some applications of the present invention.
Annular element 244 has an upper surface 241 and a lower surface
243. Tissue anchors 230 are coupled to lower surface 234 of annular
element. Tissue anchors 230 are shaped so as to define a pointed
distal tip 234 and one or more (e.g., three, as shown)
radially-expandable prongs 232. Prongs 232 comprise a flexible
metal, e.g., nitinol or stainless steel, and have a tendency to
expand radially. Anchors 230 facilitate coupling of valve support
240 to annulus 11 of native valve 5, such as the mitral valve or
the tricuspid valve. Anchors 230 are typically distributed
approximately evenly around lower surface 243 of annular element
244. For some applications, one or more anchors 230 are disposed at
a location of annular element that is configured to be positioned
adjacently to commissures 8 and 10 of valve 5.
Reference is now made to FIGS. 19A-D which are schematic
illustrations of valve support 240 being implanted at valve 5 and
the subsequent coupling of prosthetic valve 80 to valve support
240. Valve support 240 is advanced toward native valve 5 by pushing
elements 52a and 52b, as described hereinabove with respect to
valve support 40 with reference to FIGS. 2D-F. In response to the
pushing force to valve support 240 by pushing elements 52a and 52b,
anchors 230 are pushed into tissue of annulus 11 of valve 5. The
pushing force by elements 52a and 52b is sufficient to implant each
one of the plurality of anchors that are distributed around lower
surface 243 of annular element 244.
FIG. 19A shows initial penetration of tissue of annulus 11 by
pointed distal tip 234 of anchor 230. In FIG. 19B, the initial
force of the tissue on prongs 232 pushes inwardly prongs 232.
Finally, in FIG. 19C, prongs 232 expand within tissue of annulus 11
to assume a flower shape and a larger surface area to restrict
proximal motion of anchor 230 and thereby anchor valve support 240
in tissue of annulus 11. As shown in FIGS. 19A-C, the cylindrical
element of valve support 240 pushes aside native leaflets 12 and 14
of valve 5.
In FIG. 19D, prosthetic valve 80 is coupled to valve support 240,
in a manner as described hereinabove.
It is noted that, in general, prosthetic valve 80 is
self-expandable. When the prosthetic valve is deployed (i.e., when
the valve self-expands) inside the subject's heart, the expansion
of the valve is typically constrained by valve support 40. Further
typically, the expansion of the valve is not constrained by the
native annulus.
For some application, by constraining the expansion of the
prosthetic valve with the valve support, the deployed
cross-sectional area of the prosthetic valve may be fixed at a
given area, by using a valve support that defines a hole having the
given cross-sectional area. As described hereinabove with reference
to FIG. 10, for some applications, the area defined by the native
annulus is measured, and the cross-sectional area of the prosthetic
valve that is to be deployed in the valve is selected based upon
the measured area of the native annulus. Alternatively or
additionally, valve support 40 is selected based upon the measured
area of the native annulus.
For example, a valve support may be selected such that the valve
support constrains the expansion of the prosthetic valve, when the
cross-sectional area of the prosthetic valve is less than 90%
(e.g., less than 80%, or less than 60%) of the area defined by the
native annulus. As described hereinabove, for some applications,
placing a prosthetic valve inside the native valve with the
dimensions of the native valve annulus and the prosthetic valve
being as described, facilitates sealing of the prosthetic valve
with respect to the native valve, by the native valve leaflets
closing around the outer surface of the prosthetic valve.
For some applications, the expansion of prosthetic valve 80 against
valve support 40 couples the prosthetic valve to the valve support,
and/or couples the valve and the valve support to the native mitral
valve. Typically, the expansion of the prosthetic valve against the
valve support couples the prosthetic valve to the valve support,
and sandwiching of the native valve leaflets between protrusions
from the distal end of the valve and the valve support couples the
prosthetic valve and the valve support to the native valve.
Reference is now made to FIGS. 1A-D, 2A-K, 3A-D, 4A-C, 5A-D, 6A-B,
7A-F, 8A-C, 9A-H, 10, 11A-D, and 12A-C. It is to be noted that
valve support 40 may be invertible as described hereinabove with
respect to valve supports 140 and 300, with reference to FIGS.
8A-C, and 9A-H. It is to be further noted that valve supports 140
and 300 may be used in conjunction with one or more of the elements
for facilitating sealing of the native valve with respect to a
valve support or a valve that is described with reference to FIGS.
3A-D, 4A-C, 5A-D, and 6A-B. For example, valve supports 140 and 300
may be used with sealing balloon 90, commissural anchors 100a and
100b, grasping elements 106a and 106b, and/or sealing material 110.
It is still further noted that valve supports 140 and 300 may be
implanted using a guide member that defines a looped portion
between commissures 8 and 10, as described with reference to FIGS.
7A-F. It is further noted that any of the applications described
herein can be used in conjunction with valves having configurations
as described with reference to FIGS. 10-12C.
The systems described herein are advanced toward valve 5 in a
transcatheter procedure, as shown. It is to be noted, however, that
the systems described herein may be advanced using any suitable
procedure, e.g., minimally-invasively (e.g., via a transeptal, a
transatrial, a transapical, and/or a transaortic approach), or
using an open-heart procedure. It is to be further noted that valve
supports and prosthetic valves herein may be used to replace native
mitral valves or native tricuspid valves.
Reference is now made to FIGS. 20A-B, which are schematic
illustrations of valve support 40 and prosthetic valve 80 coupled
respectively to a tricuspid valve, and to an aortic valve, in
accordance with some applications of the present invention. For
some applications, valve support 40 and prosthetic valve 80 are
deployed at a tricuspid valve and/or at an aortic valve using
generally similar techniques to those described herein with
reference to the deployment of the valve support and the prosthetic
valve at the mitral valve, mutatis mutandis.
It will be appreciated by persons skilled in the art that the
present invention is not limited to what has been particularly
shown and described hereinabove. Rather, the scope of the present
invention includes both combinations and subcombinations of the
various features described hereinabove, as well as variations and
modifications thereof that are not in the prior art, which would
occur to persons skilled in the art upon reading the foregoing
description.
* * * * *
References